ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00054132
Conditions: Recurrent Breast Carcinoma Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2002-12-01; Completion date: 2015-04-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well erlotinib hydrochloride and bevacizumab work in treating patients with stage IV breast cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Giving erlotinib hydrochloride and bevacizumab may be an effective treatment for breast cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the efficacy of bevacizumab in combination with OSI-774 (erlotinib hydrochloride) in patients with previously treated metastatic breast cancer, as measured by objective response rate.

SECONDARY OBJECTIVES:

I. To determine the toxicity of bevacizumab in combination with OSI-774 in patients with previously treated metastatic breast cancer.

II. To evaluate the efficacy of bevacizumab in combination with OSI-774 in patients with previously treated metastatic breast cancer, as measured by time to disease progression, duration of response and the proportion of patients with stabilization of disease \>= 6 months.

III. To determine the molecular profile of the patient's primary breast tumor, and to explore the relationship between these molecular characteristics and the response to treatment.

IV. To explore changes in biological markers in pre- and post-treatment tumor tissue in a subset of patients with accessible sites of disease.

V. To explore a pre- and post-treatment analysis of circulating endothelial cells and the relationship of this analysis to serum markers of angiogenesis as well as response to treatment.

VI. To obtain serial measurements of circulating epithelial cells and explore the relationship of these cells with circulating endothelial cells, markers of angiogenesis, and epidermal growth factor receptor (EGFR) expression.

OUTLINE:

Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21 and bevacizumab intravenously (IV) over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Arms: arm 1: Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Bevacizumab intervention 2: Erlotinib Hydrochloride intervention 3: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00301821
Conditions: Lymphoma
Keywords: contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2006-01-01; Completion date: 2015-04-01
Enrollment: 107 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.\> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.

Detailed description:
OBJECTIVES:\> Primary\>

* Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma.\>
* Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.\>
* Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen.\>
* Assess the safety of this treatment regimen.\> Secondary\>
* Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen.\> OUTLINE: This is a multicenter study.\> Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\> After completion of study treatment, patients are followed periodically for up to 5 years.\> PROJECTED ACCRUAL: A total of 86 patients will be accrued for this study.\>

Arms: arm 1: One arm open label.
Interventions: intervention 1: epratuzumab intervention 2: rituximab intervention 3: cyclophosphamide intervention 4: doxorubicin hydrochloride intervention 5: prednisone intervention 6: vincristine sulfate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT00593450
Conditions: Age Related Macular Degeneration
Keywords: bevacizumab ranibizumab choroidal neovascularization
Sponsor: University of Pennsylvania
Start date: 2008-02-01; Completion date: 2015-04-01
Enrollment: 1208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.

A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.

Detailed description:
Age related macular degeneration (AMD) is the leading cause of severe vision loss in people over the age of 65 in the United States and other Western countries. More than 1.6 million people in the US currently have one or both eyes affected by the advanced stage of AMD.

Lucentis® is the most effective treatment for neovascular AMD studied to date. Bevacizumab (Avastin®) and Lucentis® are derived from the same monoclonal antibody. Following the encouraging clinical trial results with Lucentis®, several investigators began evaluating intravitreal Avastin® for the treatment of CNV. Given its molecular similarity to Lucentis, its low cost, and its availability, the interest in Avastin® has been considerable. Avastin® has not been evaluated relative to Lucentis®.

In addition, previous studies do not answer the question of whether a reduced dosing schedule is as effective as a fixed schedule of monthly injections. Treatment dependent on clinical response has the potential to reduce the treatment burden to patients as well as to reduce the overall cost of therapy.

Only a single eye in each patient was analyzed.

At the five year follow-up visit, the subjects will undergo the same examinations and procedures as in the original study; however, the five year follow-up visit deos not involve any study treatment.

Arms: arm 1: Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing. arm 2: Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing. arm 3: Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity. arm 4: Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Interventions: intervention 1: ranibizumab intervention 2: bevacizumab
Intervention descriptions: intervention 1: • 0.5 mg (0.05 mL)intravitreal injection intervention 2: • 1.25 mg (0.05 mL)intravitreal injection

Protocol documents:
Clinical trial NCT00617656
Conditions: Non Small Cell Lung Cancer BRCA1 Mutation
Keywords: Lung Cancer Chemotherapy Personalized medicine
Sponsor: Spanish Lung Cancer Group
Start date: 2008-02-01; Completion date: 2015-04-01
Enrollment: 382 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective:

· Progression free survival.

Secondary objectives:

* Assess Overall survival of both treatment groups.
* Assess Tumor response rate using RECIST criteria
* Assess Toxicity profile of patients enrolled in the study.
* Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy.

Detailed description:
Study population:

Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status (ECOG 0-1) and measurable disease (at least one target lesion according to RECIST criteria).

Duration of treatment:

Six chemotherapy cycles will be given. The duration of every cycle will be 21 days. If the treatment is beneficial, it may be prolonged to a total of 8 cycles at the discretion of the investigator.

Calendar and planned finalization date:

The approximate duration of the study is 3 years of recruitment followed by 1 year of follow-up.

Arms: arm 1: Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6 arm 2: Low RAP expression and any levels of BRCA1 expression: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6 arm 3: Intermediate or high RAP expression and low or intermediate BRCA1 expression: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6 arm 4: Intermediate or high RAP expression and high BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
Interventions: intervention 1: Cisplatin, Docetaxel intervention 2: Gemcitabine, Cisplatin intervention 3: Docetaxel, Cisplatin intervention 4: Docetaxel
Intervention descriptions: intervention 1: Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6 intervention 2: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6 intervention 3: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6 intervention 4: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Protocol documents:
Clinical trial NCT00631371
Conditions: Renal Cell Carcinoma
Keywords: temsirolimus renal cell carcinoma kidney cancer urogenital cancer
Sponsor: Pfizer
Start date: 2008-04-01; Completion date: 2015-04-01
Enrollment: 791 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.

Detailed description:

Arms: arm 1: Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly arm 2: Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
Interventions: intervention 1: Bevacizumab intervention 2: Temsirolimus intervention 3: Bevacizumab intervention 4: Interferon-Alfa 9MU
Intervention descriptions: intervention 1: Bevacizumab 10 mg/kg intravenous (IV) q8wks intervention 2: Temsirolimus 25 mg IV weekly intervention 3: Bevacizumab 10 mg/kg intravenous (IV) q8wks intervention 4: Interferon-Alfa 9MU SC TIW

Protocol documents:
Clinical trial NCT00642759
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC Abraxane Carboplatin Bevacizumab Avastin
Sponsor: Massachusetts General Hospital
Start date: 2008-04-01; Completion date: 2015-04-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to learn more about whether the combination of drugs carboplatin, Abraxane and Avastin helps treat non-small cell lung cancer (NSCLC). One of the standard treatments for advanced NSCLC is the combination of the drugs carboplatin, paclitaxel and Avastin. Paclitaxel can be associated with severe side effects that may make the treatment difficult to tolerate. Some of these side effects are caused by the solution used to dissolve paclitaxel before it can be administered. Abraxane is a different form of paclitaxel that does not need to be dissolved by this solution. Abraxane is approved for the treatment of breast cancer but is not approved to treat NSCLC. We will also be trying to learn more about how the drug Avastin may work to treat cancer.

Detailed description:
* Participants will receive a single dose of Avastin 2 weeks before they are scheduled to start the combination of carboplatin, Abraxane and Avastin. Before the dose of Avastin is given, a perfusion CT scan and blood work will be performed. The perfusion CT scan and blood draw will be repeated 12 days after teh Avastin dose (2 days before beginning study treatment).
* The combination of carboplatin, Abraxane and Avastin will be given in 3 week cycles and all drugs will be given as infusions. On day 1, Avastin, Abraxane and carboplatin wil be given. On Day 8 and 15, Abraxane will be given.

Participants can receive up to 6 cycles of carboplatin, Abraxane and Avastin if their disease does not get worse and they do not experience intolerable side effects.

* The following assessment procedures will be performed on day 1 of each cycle: physical exam; routine urine test (every other cycle); Performance status assessment. Routine blood tests will be performed on days 1, 8 and 15.
* Additional procedures performed after cycles 2 and 4 and at 6 months after beginning study treatment are as follows: CT scan, PET scan, perfusion CT and blood work.
* After 6 cycles of carboplatin, Abraxane and Avastin, participants will receive Avastin alone for three weeks. Participants can continue to receive Avastin as long as they do not experience unacceptable side effects.

Arms: arm 1: Carboplatin, nab-paclitaxel, and bevacizumab
Interventions: intervention 1: carboplatin intervention 2: Nab-paclitaxel intervention 3: Bevacizumab
Intervention descriptions: intervention 1: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles intervention 2: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles intervention 3: IV infusion

Protocol documents:
Clinical trial NCT00777049
Conditions: Breast Cancer
Sponsor: Translational Research in Oncology
Start date: 2009-02-01; Completion date: 2015-04-01
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the benefit of oral panobinostat monotherapy given to women with HER2-negative locally recurrent or metastatic breast cancer.

Detailed description:
This was a phase II, open label, multi-centre, two-arm, two-stage design, international study of oral panobinostat in women with HER2-negative locally recurrent or metastatic breast cancer.

In the first stage of the trial, 21 evaluable patients HR+ (ER+ and/or PgR+), HER2-negative, were to be treated (Arm I); if less than 3 responses were observed, that arm would be stopped and the treatment in this patient population would be declared as ineffective. In the other arm, 27 evaluable patients HR- (ER- and PgR-), HER2-negative, were to be treated (Arm II); if less than 2 responses were observed, that arm would be stopped and the treatment in this patient population would be declared as ineffective.

Given these protocol conditions, the study was stopped in Arm II due to low recruitment as there was insufficient data available to draw conclusions regarding efficacy in that arm. It should also be noted that only one response was observed in this group.. In Arm I, among the 25 evaluable patients, the study did not achieve the required number of tumor responses to allow enrolment to continue.

As such the protocol was amended to stop enrolment and remove analysis of the initially planned secondary objectives (Progression Free Survival and Overall Survival) considering the small study sample size. The patients already included were given the option to continue in the study until they reached their planned end-of-study visit.

Arms: arm 1: Panobinostat oral 40 mg (3 times a week) given every other week as part of a 28 day cycle. arm 2: Panobinostat oral 40 mg (3 times a week) given every other week as part of a 28 day cycle.
Interventions: intervention 1: Panobinostat
Intervention descriptions: intervention 1: Hard gelatine capsule - 5mg and 20mg

Protocol documents:
Clinical trial NCT00871169
Conditions: Pancreatic Cancer
Keywords: Irinotecan Oxaliplatin Cetuximab Advanced or metastatic pancreatic cancer
Sponsor: New Mexico Cancer Research Alliance
Start date: 2008-10-01; Completion date: 2015-04-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the side effects and how well irinotecan hydrochloride, oxaliplatin and cetuximab work in treating patients with unresectable or metastatic pancreatic cancer. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving irinotecan hydrochloride together with oxaliplatin and cetuximab may kill more tumor cells.

Detailed description:
The investigators will evaluate the side effects and how well irinotecan hydrochloride, oxaliplatin and cetuximab work in treating patients with unresectable or metastatic pancreatic cancer. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving irinotecan hydrochloride together with oxaliplatin and cetuximab may kill more tumor cells.

Arms: arm 1: The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)
Interventions: intervention 1: Irinotecan, oxaliplatin, and cetuximab
Intervention descriptions: intervention 1: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).

The treatment interval (one cycle) is every 14 days.

Protocol documents:
Clinical trial NCT00974233
Conditions: Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Keywords: CLL SLL
Sponsor: University of Wisconsin, Madison
Start date: 2009-10-01; Completion date: 2015-04-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill).

The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.

Detailed description:

Arms: arm 1: Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Interventions: intervention 1: Bendamustine intervention 2: Rituximab intervention 3: Lenalidomide
Intervention descriptions: intervention 1: 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles intervention 2: 375 mg/m2 Day 1 every 28 days for 6 cycles intervention 3: 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.

Protocol documents:
Clinical trial NCT00985946
Conditions: Neuroendocrine Tumors
Sponsor: University of Wisconsin, Madison
Start date: 2010-05-01; Completion date: 2015-04-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This summary will use Panobinostat (LBH589) in patients with neuroendocrine tumors to see how the patient's tumor responds to panobinostat. Additionally, this study will examine how long it takes neuroendocrine tumor patient's cancer to progress while taking the drug and examine the overall survival of patients using panobinostat. Also, the study will examine the toxicity and tolerability of panobinostat in the patient population. Finally, this study will look at the effect of panobinostat on Notch 1 signaling before and after treatment with panobinostat.

Detailed description:

Arms: arm 1: This is a single arm trial. All patients will take panobinostat
Interventions: intervention 1: panobinostat (LBH589)
Intervention descriptions: intervention 1: Panobinostat will be taken once daily at 20 mg three times a week (every Monday, Wednesday, Friday). It will be taken as long as patients are benefiting from treatment.

Protocol documents:
Clinical trial NCT00997126
Conditions: Sedation
Keywords: propofol alfentanil nitrous oxide moderate procedural sedation Moderate Procedural Sedation in the Emergency Department
Sponsor: Hennepin Healthcare Research Institute
Start date: 2009-10-01; Completion date: 2015-04-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).

Detailed description:
This was initially going to be a trial of propofol vs alfentanil vs nitrous oxide, but our use of nitrous oxide was discontinued before the trial began and the trial was conducted with only two arms

Arms: arm 1: Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation arm 2: Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
Interventions: intervention 1: Propofol intervention 2: Alfentanil
Intervention descriptions: intervention 1: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation intervention 2: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation

Protocol documents: