ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00499473
Conditions: Adult Anaplastic Astrocytoma Adult Diffuse Astrocytoma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Mixed Glioma Adult Oligodendroglioma Adult Pineal Gland Astrocytoma
Sponsor: National Cancer Institute (NCI)
Start date: 2007-06-01; Completion date: 2014-10-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial is studying how well sunitinib works in treating patients with recurrent malignant gliomas. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the efficacy of sunitinib malate in patients with recurrent malignant gliomas as measured by 6-month progression-free survival.

II. To determine the lower of the dose of sunitinib malate in patients receiving enzyme-inducing anti-convulsants that would achieve similar serum drug and metabolite concentrations as that in patients not receiving enzyme-inducing anticonvulsants or the maximum tolerated dose in the same population.

SECONDARY OBJECTIVES:

I. To examine the toxicity and safety of sunitinib malate in patients with the above noted tumors.

II. To evaluate tumor responses in the stated patients. III. To evaluate progression-free and overall survival in the stated patients.

OUTLINE: This is a multicenter study. Patients are stratified according to use of enzyme-inducing anticonvulsants (EIAC) (yes vs no).

STRATUM 1 (non-EIAC): Patients receive oral sunitinib malate once daily for 4 consecutive weeks followed by 2 weeks of rest.

STRATUM 2 (EIAC \& OSU patients only): Patients receive oral sunitinib malate as in stratum 1. Patients receive escalating doses of oral sunitinib malate until the maximum tolerated dose (MTD) is determined.

Patients undergo blood sample collection periodically for pharmacokinetic studies. Samples are analyzed for plasma concentrations of sunitinib malate via LC/MS/MS method.

In both strata, treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Non-EIAC patients receive oral sunitinib malate once daily for 4 consecutive weeks followed by 2 weeks of rest. arm 2: EIAC \& OSU patients receive oral sunitinib malate as in stratum 1. Patients receive escalating doses of oral sunitinib malate until the maximum tolerated dose (MTD) is determined.
Interventions: intervention 1: sunitinib malate intervention 2: pharmacological study
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00563290
Conditions: Recurrent Skin Cancer Squamous Cell Carcinoma of the Skin Stage 0 Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2007-11-01; Completion date: 2014-10-01
Enrollment: 7 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial is studying how well dasatinib works in treating patients with unresectable or metastatic squamous cell skin cancer or RAI Stage 0-I chronic lymphocytic leukemia. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the objective response rate (complete response and partial response) in patients with unresectable or metastatic squamous cell carcinoma of the skin or RAI stage 0-I chronic lymphocytic leukemia receiving dasatinib.

SECONDARY OBJECTIVES:

I. Determine the progression-free survival of patients receiving this drug. II. Evaluate tumor for presence of total EphA2 and both total and active Src and FAK by immunohistochemistry (IHC) pre-treatment with dasatinib.

III. Evaluate tumor for presence of cyclooxygenase-2 by IHC pre-treatment with dasatinib.

OUTLINE: Patients are assigned to 1 of 2 treatment arms.

ARM I: Patients receive 100 mg dasatinib orally (PO) twice daily (BID) on days 1-28.

ARM II (PATIENTS ENROLLED AFTER 11/18/08): Patients receive 70 mg dasatinib PO BID on days 1-28.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Pre-therapy tumor biopsy specimens are collected to detect total and phosphorylated Src and FAK, total EphA2, and cyclooxygenase-2 by immunohistochemistry.

After completion of study treatment, patients are followed up monthly for up to 12 weeks.

Arms: arm 1: Patients receive 100 mg dasatinib PO BID on days 1-28 arm 2: Patients receive 70 mg dasatinib PO BID on days 1-28
Interventions: intervention 1: dasatinib intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00589784
Conditions: CNS Cancer Meningioma Intracranial Hemangiopericytoma Hemangioblastoma Neurofibromatosis
Keywords: Sunitinib Brain Cancer CNS Cancer meningioma intracranial hemangiopericytoma hemangioblastoma malignant meningioma neurofibromatosis neurofibromatosis type 1 neurofibromatosis type 2 07-135
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2007-10-01; Completion date: 2014-10-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what effects, good and/or bad, sunitinib has on patients and their tumors. At this time, no drugs are routinely used to treat meningioma, hemangioblastoma or hemangiopericytoma. Only surgery and radiation therapy are known to be useful.

Sunitinib is a drug approved for advanced kidney cancer. Sunitinib is also being studied for other tumors. It may be useful in the treatment of brain tumors because it can prevent formation of new blood vessels that allow tumor cells to survive and grow.

Detailed description:
This is a phase II study of Sunitinib in patients with recurrent or inoperable meningiomas. An exploratory study will be performed for patients with recurrent hemangiopericytoma or hemangioblastoma. There will be approximately 50 patients enrolled on this study (40 meningiomas and 10 hemangiopericytomas/hemangioblastomas). The treatment plan is to use daily SU11248 at a dose of 50 mg, using the established schedule of 4 weeks of treatment followed by two weeks of rest period, forming a six-week treatment cycle. A medical professional will see each patient at least every six weeks while on the medication for toxicity assessment and physical examination. Extent of disease evaluations will occur at baseline, two weeks, twelve weeks, 24 weeks, and every twelve weeks thereafter. These evaluations will include MRI of the brain (or CT head if a patient cannot undergo MRI) and MR perfusion.

Arms: arm 1: Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks, followed by a two-week rest period. Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered. Imaging studies will be performed after every other cycle. Patients may continue on study as long as they are tolerating treatment and in the absence of disease progression.
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: The study drug will be administered on an outpatient basis. The starting dose will be 50 mg daily for 28 days (4 consecutive weeks) followed by 14 days off for patients not on CYP3A4 inducers or inhibitors. A cycle equals 42 days.

Protocol documents:
Clinical trial NCT00593866
Conditions: Pancreatic Cancer
Keywords: Patients who have confirmed cancer arising from the pancreas
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2006-06-01; Completion date: 2014-10-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.

Detailed description:

Arms: arm 1: INTENSITY MODULATED RADIOTHERAPY

Radiation dose escalation:

Total dose Dose per fraction BED\* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4

* BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level

Gemcitabine:

1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
Interventions: intervention 1: INTENSITY MODULATED RADIOTHERAPY intervention 2: Gemcitabine
Intervention descriptions: intervention 1: Five fractions weekly, fraction size determined by dose level intervention 2: 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment

Protocol documents:
Clinical trial NCT00688753
Conditions: Carcinoma Renal Cell Non Clear Cell Renal Carcinoma Papillary Cell Renal Carcinoma Adenocarcinoma
Keywords: renal cell carcinoma non clear cell carcinoma papillary cell renal carcinoma adults everolimus
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-01; Completion date: 2014-10-01
Enrollment: 92 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.

Detailed description:

Arms: arm 1: two 5 mg tablets of everolimus orally, once daily
Interventions: intervention 1: RAD001
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00717405
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-10-01; Completion date: 2014-10-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Standard chemotherapy intervention 2: bevacizumab [Avastin] intervention 3: trastuzumab [Herceptin]
Intervention descriptions: intervention 1: As prescribed intervention 2: 15mg/kg iv 3 weekly in cycles 1-8 intervention 3: 8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.

Protocol documents:
Clinical trial NCT00744055
Conditions: Alcohol Dependence Stress Disorders, Post-Traumatic
Keywords: alcohol dependence post traumatic stress disorder treatment prazosin
Sponsor: Yale University
Start date: 2009-01-01; Completion date: 2014-10-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prazosin is an alpha-1 adrenergic receptor antagonist that has been used successfully in the treatment of trauma nightmares and sleep disturbance in combat veterans with PTSD, and alcohol dependence.

The objective of this study is to evaluate the efficacy of prazosin (16mg) versus placebo in reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid AD and PTSD.

Detailed description:
Background:

There is a high rate of comorbidity with alcohol dependence (AD) and post traumatic stress disorder (PTSD). The rates of PTSD among individuals with AD are at least twice as high as those in the general population. In addition, alcohol dependence is the most common comorbid condition in men with PTSD. Despite this, little is known about how to best treat individuals with comorbid AD and PTSD. The use of an alpha-1 adrenergic receptor antagonist represents a novel approach to treatment that may target symptoms of both AD and PTSD. There is evidence of common neurobiological mechanisms that underlie both AD and PTSD. Prazosin is an alpha-1 adrenergic receptor antagonist that has been used successfully in the treatment of trauma nightmares and sleep disturbance in combat veterans with PTSD, and alcohol dependence.

Objective:

The objective of this study is to evaluate the efficacy of prazosin (16mg) versus placebo in reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid AD and PTSD. Methods: Thirty participants with a current diagnosis of AD and PTSD will be enrolled in a 13-week trial. They will be assigned, in a double-blind fashion, to either prazosin or placebo. Significance: This project will be the first to compare prazosin to placebo as effective treatments for reducing alcohol consumption and PTSD symptoms in patients with both AD and PTSD.

Arms: arm 1: prazosin (16mg/day) arm 2: Placebo in identical looking capsule blister packs
Interventions: intervention 1: Prazosin intervention 2: Placebo
Intervention descriptions: intervention 1: prazosin (16mg/day) 2 times a day intervention 2: Placebo

Protocol documents:
Clinical trial NCT00793871
Conditions: Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Keywords: sunitinib Phase IV gastrointestinal stomal tumor imatinib resistant or intolerant Chinese
Sponsor: Pfizer
Start date: 2008-11-01; Completion date: 2014-10-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.

Detailed description:

Arms: arm 1: single agent sunitinib, single arm
Interventions: intervention 1: Sunitinib Malate (SU011248)
Intervention descriptions: intervention 1: Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.

Protocol documents:
Clinical trial NCT00821886
Conditions: Breast Cancer
Keywords: Breast Cancer Neoadjuvant Ixabepilone Carboplatin Trastuzumab
Sponsor: SCRI Development Innovations, LLC
Start date: 2009-02-01; Completion date: 2014-10-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this phase II trial the investigators propose to evaluate ixabepilone in combination with carboplatin and trastuzumab as neoadjuvant therapy in locally advanced breast cancer patients. Patients with early stage, HER2-positive breast cancer will receive six cycles of neoadjuvant treatment with ixabepilone, carboplatin, and trastuzumab every three weeks prior to surgery; after surgery, patients will continue treatment with trastuzumab every three weeks until week 52. Concomitant with the post-operative trastuzumab treatment, patients with hormone receptor-positive tumors will receive anti-estrogen treatment. Also, after the completion of chemotherapy, patients may receive radiation treatment at the discretion of their physician.

Detailed description:

Arms: arm 1: Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate
Interventions: intervention 1: Ixabepilone intervention 2: Trastuzumab intervention 3: Carboplatin
Intervention descriptions: intervention 1: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length) intervention 2: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52 intervention 3: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)

Protocol documents:
Clinical trial NCT00828984
Conditions: Adenomatous Polyp Colorectal Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2009-10-01; Completion date: 2014-10-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well macrogol 3350-based oral osmotic laxative (polyethylene glycol 3350) works in preventing cancer in patients at risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of macrogol 3350-based oral osmotic laxative may stop cancer from growing in patients who are at risk of colorectal cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the effect of polyethylene glycol (PEG) 3350 (administered at 8 g or 17 g/day for six months) versus placebo on epidermal growth factor receptor (EGFR) expression.

SECONDARY OBJECTIVES:

I. To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8 g PEG 3350/day) and higher dose (17 g PEG 3350/day) groups.

II. To determine the effect of PEG 3350 on mucosal epithelial proliferation (marker of proliferation Ki-67 \[Ki-67\]).

III. To determine the effect of PEG 3350 on mucosal apoptosis (cleaved caspase-3).

IV. To determine the effect of PEG 3350 on snail family zinc finger 1 (SNAIL) protein expression.

V. To determine the effect of PEG 3350 on messenger ribonucleic acid (mRNA) expression of SNAIL and EGFR.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A: Patients receive high-dose macrogol 3350-based oral osmotic laxative orally (PO) once daily (QD).

ARM B: Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD.

ARM C: Patients receive placebo (i.e., maltodextrose powder) PO QD.

In all arms, treatment begins within 6-10 days after colonoscopy and continues for up to 6 months in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days.

Arms: arm 1: Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity. arm 2: Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity. arm 3: Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.
Interventions: intervention 1: macrogol 3350-based oral osmotic laxative intervention 2: Placebo intervention 3: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00856661
Conditions: Stroke
Keywords: Acute ischemic stroke Angiography Desmoteplase Thrombolytic
Sponsor: H. Lundbeck A/S
Start date: 2009-04-01; Completion date: 2014-10-01
Enrollment: 270 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3 to 9 hours from onset of stroke symptoms.

Detailed description:
Acute stroke is a major cause of mortality and long-term disability in the developed world. The only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the majority of strokes, is alteplase (recombinant tissue plasminogen activator; rtPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of acute stroke subjects are treated. The thrombolytic agent desmoteplase (recombinant Desmodus Salivary Plasminogen Activator alpha-1; rDSPAalpha-1) produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat Desmodus rotundus. Compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin specificity and non neurotoxicity.

The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischaemic stroke in the extended time window of 3 to 9 hours after onset of stroke symptoms.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Desmoteplase intervention 2: Placebo
Intervention descriptions: intervention 1: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes on 1st day intervention 2: IV, single bolus over 1 to 2 minutes on 1st day

Protocol documents:
Clinical trial NCT00866905
Conditions: Breast Cancer
Keywords: Breast Cancer Ixabepilone Ixempra Cyclophosphamide Cytoxan Neoadjuvant Therapy
Sponsor: SCRI Development Innovations, LLC
Start date: 2009-04-01; Completion date: 2014-10-01
Enrollment: 168 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical

studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The combination of ixabepilone and cyclophosphamide could further improve the efficacy of non-anthracycline neoadjuvant therapy.

Detailed description:
In this study, patients with early stage, HER2-negative breast cancer will receive neoadjuvant treatment with ixabepilone and cyclophosphamide given every three weeks for a total of six cycles. Following surgery patients with hormone receptor-positive tumors will receive anti-estrogen treatment. Patients may receive local regional radiation therapy after surgery per institutional guidelines at the investigator's discretion. Baseline tumor tissue and tumor tissue removed at the time of surgery will be tested by Oncotype Detailed Description (DX) assay to determine whether it is predictive of response to this neoadjuvant treatment regimen. This study will be one of the first investigations of the combination of ixabepilone and cyclophosphamide as neoadjuvant treatment for HER2-negative breast cancer. It will examine this treatment regimen for potential advantages gained from substitution of ixabepilone for a taxane and use of non-anthracycline agents.

Arms: arm 1: Systemic Therapy followed by surgery and possible radiation therapy
Interventions: intervention 1: Ixabepilone intervention 2: Cyclophosphamide
Intervention descriptions: intervention 1: 40 mg/m2 IV infusion over 3 hours on day 1 of a 21 day cycle for 6 cycles intervention 2: 600 mg/m2 IV infusion per institutional guidelines on day 1 of a 21 day cycle for 6 cycles

Protocol documents: