ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00148668
Conditions: Breast Cancer
Keywords: HER-2 Positive Breast Cancer herceptin navelbine taxotere carboplatin Early stage Breast Cancer
Sponsor: Eric Winer, MD
Start date: 2003-12-01; Completion date: 2011-08-01
Enrollment: 81 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.

Detailed description:
Before starting treatment, a clip will be placed via catheter into the tumor bed, so the surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be taken of the tumor. One to two weeks after the first dose of herceptin another biopsy will be performed.

Patients will be placed into one of 2 arms.

* Arm 1 receives 12 weeks of herceptin and navelbine. Arm 2 receives 4 cycles of taxotere/carboplatin/herceptin.
* Arm 2 participants will also receive neulasta (growth factor support) on day 2 of each cycle.

Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a second biopsy 1-2 weeks following this dose. Phase B of Arm 1 begins on week 3 and ends on week 14 and involves weekly injections of herceptin and navelbine. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin and navelbine.

Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and second biopsy 1-2 weeks following this dose. Phase B of Arm 2 begins on week 3 and ends on week 14 and involves herceptin weekly, taxotere and carboplatin every 3 weeks. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin, taxotere and carboplatin.

Blood tests will be performed every 3 weeks during pre-operative treatment and every 6 months after surgery.

Arms: arm 1: Herceptin/navelbine arm 2: Taxotere/carboplatin/herceptin
Interventions: intervention 1: Herceptin intervention 2: Navelbine intervention 3: Taxotere intervention 4: Carboplatin
Intervention descriptions: intervention 1: One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14. intervention 2: Weekly injections given starting week 3 and ending week 14 intervention 3: Given every three weeks starting week 3 and ending on week 14 intervention 4: Given every three weeks starting week 3 and ending on week 14

Protocol documents:
Clinical trial NCT00168064
Conditions: Mycosis Fungoides
Keywords: Mycosis Fungoides Nitrogen Mustard Cutaneous T-Cell Lymphoma CTCL - Mycosis Fungoides
Sponsor: Yaupon Therapeutics
Start date: 2006-05-01; Completion date: 2011-08-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).

Detailed description:
The successful use of mechlorethamine (MCH) as a topical agent in the treatment of mycosis fungoides, a form of cutaneous T-cell lymphoma, was first reported in the late 1950s, and provided a rationale for skin-directed chemotherapy that minimized systemic toxicity. Since then, multiple investigators have demonstrated the safety and efficacy of topically applied MCH in the treatment of mycosis fungoides. This study will evaluate the efficacy (non-inferiority), tolerability and safety of topical application of MCH proprietary gel versus a compounded ointment formulation in Aquaphor in patients with stage I or IIA MF.

Arms: arm 1: PG - mechlorethamine-MCH (nitrogen mustard) 0.02% gel To evaluate the tolerability and safety of topical mechlorethamine-MCH (nitrogen mustard) 0.02% ointment formulations in patients with stage I or IIA MF arm 2: AP - mechlorethamine-MCH (nitrogen mustard) 0.02% compounded in Aquaphor To evaluate the tolerability and safety of mechlorethamine-MCH (nitrogen mustard)0.02% ointment formulations in patients with stage I or IIA MF
Interventions: intervention 1: mechlorethamine-MCH (nitrogen mustard)
Intervention descriptions: intervention 1: All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment

Protocol documents:
Clinical trial NCT00184054
Conditions: Acute Myelogenous Leukemia
Sponsor: University of Southern California
Start date: 2002-04-01; Completion date: 2011-08-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical research study is for patients with acute myelogenous leukemia (in short AML) that did not respond to previous treatment or unable to receive chemotherapy.

Arsenic has been used as a drug for many centuries. While arsenic containing drugs were used in the past for cancer treatments, the major use of arsenic in western countries has been for the treatment of uncommon tropical illnesses, such as sleeping sickness. Recently, some new information suggests that arsenic in a form called arsenic trioxide may also be useful to treat some cancers of the blood, such as leukemia, lymphoma and myeloma. Studies from China and the USA showed that patients with a type of blood cancer called acute promyelocytic leukemia, whose disease failed to respond to other treatments, responded very well to arsenic trioxide. Studies done in laboratories in the United States have shown that arsenic can kill AML cells growing in culture dishes.

Ascorbic acid (vitamin C), a natural supplement in our diet, has long been involved with cancer prevention. Laboratory tests have shown that although arsenic trioxide by itself can kill AML cells in the test tube, when vitamin C is added to arsenic trioxide in a test tube, the death of the leukemia cells increases significantly.

The purpose of this study is to find out if the combination of arsenic trioxide (Trisenox) and ascorbic acid is effective in the treatment of patients who have AML. The second purpose is to study how the two drugs affect cells in the laboratory. Samples from the blood and bone marrow (the part of the body that makes blood cells) will be collected, at specific times during treatment, in order to study them in the laboratory. By studying blood and marrow cells, researchers hope to learn the mechanisms by which the drugs work.

Detailed description:

Arms: arm 1: Arsenic Trioxide (ATO) given at 0.25 mg/kg/day intravenously for 25 days over a 35-day period.

Ascorbic Acid given at 1000 mg/day intravenously every other day that ATO is given
Interventions: intervention 1: Arsenic Trioxide (ATO) intervention 2: Ascorbic Acid
Intervention descriptions: intervention 1: Arsenic Trioxide .25 mg/kg/day intervention 2: Ascorbic Acid 1000 mg every other day for 25 days

Protocol documents:
Clinical trial NCT00193258
Conditions: Clear Cell Renal Cell Carcinoma
Keywords: Recurrent clear cell renal cell carcinoma Bevacizumab Erlotinib Imatinib
Sponsor: SCRI Development Innovations, LLC
Start date: 2004-06-01; Completion date: 2011-08-01
Enrollment: 94 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been demonstrated, the mild to moderate side effects of all of these agents are not predicted to cause prohibitive toxicity. A brief phase I portion will be included in this trial, to optimize doses of the 3 agents prior to proceeding with the phase II trial.

Detailed description:
Upon determination of eligibility, patients will be receive:

Bevacizumab + Erlotinib + Imatinib

A brief phase I dose escalation study will be performed to define the imatinib dose that will be used.

Arms: arm 1: In the phase I portion:

Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course

Erlotinib 150 mg orally daily

Imatinib 300 mg orally daily or 400 mg orally daily

In the phase II portion:

Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle

Erlotinib 150 mg orally daily

Imatinib 400 mg orally daily
Interventions: intervention 1: Bevacizumab intervention 2: Erlotinib intervention 3: Imatinib
Intervention descriptions: intervention 1: 10mg/kg IV infusion every 2 weeks intervention 2: 150 mg po daily intervention 3: 400-600mg daily

Protocol documents:
Clinical trial NCT00254488
Conditions: Bipolar Disorder Mania
Sponsor: Weill Medical College of Cornell University
Start date: 2005-11-01; Completion date: 2011-08-01
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.

Detailed description:
This is the first controlled acute treatment study of bipolar disorder in adults 60 years or older with current DSM-IV manic, mixed, or hypomanic episodes. The number of older adults with severe and disabling bipolar disorder is increasing, and information to guide the management of the treatment of the disease is lacking in this population. Guidelines for treatment of younger people with bipolar disorder cannot be used for older people, and there are no safety and efficacy data upon which to base initial treatment decisions for older patients with bipolar mania. Mood stabilizers (lithium and divalproex) are the first-line treatment for bipolar disorder. However, in aged patients physiological changes and comorbid diseases may increase vulnerability to side effects and limit the benefits of the medications.

This double-blind study will compare the benefits and side-effects of 9 weeks of treatment with lithium and divalproex in people with bipolar mania. Participants, who may be treated during inpatient hospitalization or as outpatients, will be randomly assigned to receive either lithium or divalproex. During the first 3 weeks of treatment careful titration of lithium and divalproex will be done to reach dose ranges. All other psychotropic medications will be discontinued. Behavioral interventions and/or lorazepam may be added, if necessary. After the first 3 weeks, if symptoms do not improve, risperidone will be added to be taken everyday with the study medication.

Arms: arm 1: Participants will receive 9 weeks of treatment with lithium arm 2: Participants will receive 9 weeks of treatment with divalproex
Interventions: intervention 1: Lithium (LI) intervention 2: Divalproex (DV)
Intervention descriptions: intervention 1: The starting LI dose will be 150 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma LI level ranges between 0.40 and 0.99 mEq/L (target 0.80 to 0.99 mEq/L). intervention 2: Dosage of DV will be 250 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma DV level ranges between 40 and 99 mcg/mL (target 80 to 99 mcg/ml).

Protocol documents:
Clinical trial NCT00268346
Conditions: Esophageal Cancer
Keywords: adenocarcinoma of the esophagus recurrent esophageal cancer squamous cell carcinoma of the esophagus stage IV esophageal cancer
Sponsor: Case Comprehensive Cancer Center
Start date: 2005-10-01; Completion date: 2011-08-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with recurrent or metastatic esophageal or gastroesophageal junction cancer.

Detailed description:
OBJECTIVES:

Primary

* Explore the activity of single agent gefitinib, in terms of response rate, in a patient population with recurrent or metastatic esophageal or gastroesophageal junction cancer.

Secondary

* Assess the toxicity of this drug in these patients.

OUTLINE: Patients are stratified according to prior treatment (yes vs no).

Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: ZD1839
Intervention descriptions: intervention 1: ZD1839 treatment will be taken once a day PO, every day about the same time

Protocol documents:
Clinical trial NCT00270894
Conditions: Breast Neoplasm
Keywords: neoadjuvant chemotherapy HER2 positive breast cancer stage II - III breast cancer
Sponsor: Accelerated Community Oncology Research Network
Start date: 2005-11-01; Completion date: 2011-08-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients:

* trastuzumab (Herceptin)
* epirubicin (Ellence)
* cyclophosphamide (Cytoxan)
* docetaxel (Taxotere)

Detailed description:
This is an investigator-initiated, Phase II, non-randomized, single-arm, prospective treatment study. The study will consist of neoadjuvant treatment period (weeks 1 to 20), surgical evaluation period (weeks 20 to 24), and a post-surgical/follow-up period (approximately 3 years). Subjects will be treated on an outpatient basis.

Neoadjuvant therapy will consist of epirubicin + cyclophosphamide given every 2 weeks for four cycles followed by a three week break. Subjects will then receive docetaxel every two weeks for four cycles + trastuzumab (one loading dose) then maintenance dose every 2 weeks for 4 treatments.

Arms: arm 1: Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
Interventions: intervention 1: epirubicin intervention 2: cyclophosphamide intervention 3: docetaxel intervention 4: trastuzumab
Intervention descriptions: intervention 1: epirubicin (100 mg/m\^2) every 2 weeks for 4 cycles intervention 2: cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles intervention 3: docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles intervention 4: trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments

Protocol documents:
Clinical trial NCT00296816
Conditions: Ovarian Cancer
Sponsor: Sanofi
Start date: 2006-03-01; Completion date: 2011-08-01
Enrollment: 132 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Feasibility study to assess a novel combination of cytotoxic agents, docetaxel and oxaliplatin, as first-line therapy in the treatment of ovarian cancer and the impact of angiogenesis inhibition for the progression and prognosis of ovarian cancer by concurrent addition of bevacizumab (Avastin®).

Detailed description:
Participants were

* administered study medication approximately 28 days after initial surgery for ovarian cancer
* received the study treatment regimen of up to one year unless there was disease progression, unacceptable toxicity, death, participant refusal, or treatment delay beyond the time frame permitted for each treatment

Participants were followed for survival for a minimum 3 years from the date of enrollment

Arms: arm 1: Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Interventions: intervention 1: Bevacizumab (Avastin®) intervention 2: Docetaxel (Taxotere®) intervention 3: Oxaliplatin (Eloxatin®)
Intervention descriptions: intervention 1: 15 mg/kg bevacizumab administered intravenously (IV) over 30 to 90 minutes on Day 1 of every 3 week cycle for 12 months or until disease progression or unacceptable toxicity intervention 2: 75 mg/m\^2 docetaxel was administered IV over 1 hour on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity intervention 3: 85 mg/m\^2 Oxaliplatin was administered IV over 2 hours on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT00306670
Conditions: Hemophilia A
Keywords: Acquired Hemophilia A Anti-Factor VIII antibodies Anti-Factor VIII inhibitors Hemophilia A Factor VIII inhibitors
Sponsor: Georgetown University
Start date: 2006-04-01; Completion date: 2011-08-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the rate of response when administering rituximab to suppress or eliminate the anti-body in a patient's blood that inhibits the effectiveness of their factor replacement product compared to treatment using cyclophosphamide. This is a Phase 2/3 study to find out what effects (good and bad) and response rituximab has on a patient and their anti-Factor VIII antibodies. Also, to compare the effect (good and bad) of the rituximab with cyclophosphamide on a patient and their anti-Factor VIII antibodies to see which is better. This research is being done because we do not know which treatment regimen (rituximab or cyclophosphamide) is more effective in eliminating or suppressing the anti-Factor VIII antibody in patients with acquired Hemophilia A.

Detailed description:
This is a prospective Phase II randomized multi-institutional controlled pilot trial comparing the regimen of single agent rituximab with 6 weeks cytotoxic therapy with oral cyclophosphamide to eradicate or suppress autoimmune anti-factor VIII antibodies in individuals with acquired hemophilia A. Patients will be randomized to receive either of these two regimens when their autoimmune anti-factor VIII antibodies prove to be refractory to initial upfront immunosuppressive treatment with oral prednisone 1 mg/kg/day (or equivalent corticosteroid doses) for 3 weeks. Patients will be randomized to the treatment cohorts according to the biostatistical methods.

Arms: arm 1: Patients will receive rituximab. arm 2: Patients will receive oral cyclophosphamide.
Interventions: intervention 1: Rituxan intervention 2: prednisone
Intervention descriptions: intervention 1: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies intervention 2: \<30 mg/day

Protocol documents:
Clinical trial NCT00321906
Conditions: Delayed Graft Function Acute Graft Rejection
Keywords: Rejection in lung transplant
Sponsor: University of Chicago
Start date: 2002-04-01; Completion date: 2011-08-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and effectiveness of two different anti-rejection drug regimens.

Detailed description:
This multicenter prospective, randomized controlled clinical trial compared the open label use of sirolimus with that of azathioprine in a tacrolimus-based immunosuppression regimen. Eligible patients were identified during a 90-day screening period immediately after transplantation and randomized via a computer-generated scheme. Patient randomization was stratified according to center and rejection status in the first 90 days after transplantation. All patients received IL-2 receptor antagonist induction therapy, tacrolimus, azathioprine, and corticosteroids until 90 days after transplantation. At 90 days after transplantation, patients were randomized at a 1:1 ratio to either continue azathioprine or change from azathioprine to sirolimus.

The dosing and levels of immunosuppressive medications were standardized for all patients included in this study. Tacrolimus was dosed at 0.04 mg/kg twice daily with target trough levels between 5 and 15 ng/ml, azathioprine was administered at 2 mg/kg daily with dose adjustments for leukopenia, sirolimus was initially dosed at 2 mg/day with target trough levels between 5 and 15 ng/ml, and prednisone was tapered to not more than 10 mg/day by 3 months after transplantation. All patients received induction therapy with either daclizumab or basiliximab as per the product package insert.

In addition, prophylactic antimicrobials were standardized among the participating sites. All patients with either donor and/or recipient cytomegalovirus (CMV)-positive serostatus received either intravenous ganciclovir or oral valganciclovir for a total of 90 days. Lung transplant recipients who were negative for both donor and recipient CMV serostatus received valacyclovir for 90 days. Antifungal prophylaxis was determined by each site. Pneumocystis jiroveci prophylaxis was continued throughout the study. Lipid-lowering medications were recommended according to the National Cholesterol Education Program guidelines.

Arms: arm 1: (tacrolimus,azathioprine/prednisone) arm 2: tacrolimus/sirolimus/prednisone
Interventions: intervention 1: azathioprine intervention 2: sirolimus
Intervention descriptions: intervention 1: azathioprine 2mg/kg intervention 2: sirolimus 2-4mg daily

Protocol documents:
Clinical trial NCT00343044
Conditions: Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer
Keywords: platinum resistant ovarian cancer recurrent ovarian cancer platinum resistant cancer
Sponsor: Benaroya Research Institute
Start date: 2006-06-01; Completion date: 2011-08-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the clinical safety and toxicity of intravenous bevacizumab (Days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (Days 1, 8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian tube and primary peritoneal cancer.

Detailed description:
This study is designed as a Phase 2 study. There are no published data on the toxicity of the combination of bevacizumab and topotecan therapy. Based on data combining bevacizumab with other chemotherapy agents in non-gynecologic solid tumors, it is not likely that the toxicity of the combination of the two drugs will be greater than the individual toxicities of each drug. The toxicities of each of these agents is quite different. Specifically the toxicity of this combination will be studied using the dose of bevacizumab used in previous phase II studies of ovarian cancer, e.g. an equivalent of 5 mg/kg weekly with treatments given at least every 3 weeks. In our study, since topotecan will be given weeks 1,2 and 3 of an every 4 week cycle, it is convenient to give bevacizumab 10 mg/kg IV every other week.

Arms: arm 1: Subjects received standard topotecan with the addition of bevacizumab. Cycles were 28 days and continued until toxicity, progression or subject wish to discontinue treatment. Topotecan administered 4 mg/m2 IV on days 1, 8 and 15 and bevacizumab IV 10 mg/kg, days 1 and 15 of each cycle.
Interventions: intervention 1: Topotecan intervention 2: Bevacizumab
Intervention descriptions: intervention 1: Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV. intervention 2: bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.

Protocol documents: