ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00113373
Conditions: Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-05-01; Completion date: 2011-03-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well lapatinib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.

Detailed description:
OBJECTIVES: Primary I. Determine 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with lapatinib.

II. Determine the nature and degree of toxicity of this drug in these patients.

Secondary I. Determine the clinical response rate (partial and complete response) in patients treated with this drug.

II. Determine the duration of progression-free and overall survival of patients treated with this drug.

III. Determine the impact of prognostic variables, including platinum sensitivity, performance status, and cellular histology (clear cell or mucinous type), on patients treated with this drug.

IV. Correlate tumor levels of expression of epidermal growth factor receptors (EGFR), phosphorylated EGFR, HER2/neu, and Ki-67, as determined by immunohistochemistry, with clinical response in patients treated with this drug.

V. Correlate EGFR mutations in tumor DNA with clinical response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-26 months.

Arms: arm 1: Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: lapatinib ditosylate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00116428
Conditions: Heart Diseases Arrhythmia Atrial Fibrillation
Keywords: Atrial Fibrillation Paroxysmal Atrial Fibrillation
Sponsor: Biosense Webster, Inc.
Start date: 2004-10-01; Completion date: 2011-03-01
Enrollment: 167 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: NAVISTAR® THERMOCOOL® Catheter intervention 2: Antiarrhythmic drug
Intervention descriptions: intervention 1: The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes. intervention 2: Subjects randomized to the antiarrhythmic drug (control) arm will be prescribed to a not previously administered class I or class III antiarrhythmic drug that is currently approved in the U.S. for treating atrial fibrillation.

Protocol documents:
Clinical trial NCT00149214
Conditions: Breast Cancer
Sponsor: Eli Lilly and Company
Start date: 2005-09-01; Completion date: 2011-03-01
Enrollment: 257 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pemetrexed intervention 2: cyclophosphamide intervention 3: doxorubicin intervention 4: docetaxel
Intervention descriptions: intervention 1: 500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) intervention 2: 600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4) intervention 3: 60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4) intervention 4: 100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)

Protocol documents:
Clinical trial NCT00171704
Conditions: Hormone Sensitive Resected Primary Breast Cancer in Postmenopausal Women
Keywords: Breast Cancer Letrozole Bone Mineral Density Bone Markers Serum lipid Postmenopausal
Sponsor: Novartis Pharmaceuticals
Start date: 2005-04-01; Completion date: 2011-03-01
Enrollment: 263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Estrogen is known to be a regulator of bone and lipid metabolism. Letrozole is a potent inhibitor of estrogen synthesis.

This study evaluated the effects of letrozole and tamoxifen on bone and lipid metabolism in postmenopausal women with resected, receptor positive early breast cancer.

Detailed description:

Arms: arm 1: 2.5 mg once daily (q.d.)orally for 5 years arm 2: 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Interventions: intervention 1: Letrozole intervention 2: Tamoxifen
Intervention descriptions: intervention 1: 2.5 mg tablets and supplied in bottles with 6-monthly supplies. intervention 2: 20 mg tablets in bottles as 6-monthly supplies (supplied to Novartis as Tamofen from Schering Oy, Subsidiary of Schering AG, Pansiontie 47, FIN-2010 Turku, Finland)

Protocol documents:
Clinical trial NCT00187486
Conditions: Glioblastoma Multiforme Gliosarcoma
Keywords: Glioblastoma Multiforme Gliosarcoma GBM GS Tarceva Temodar Radiation Newly Diagnosed
Sponsor: University of California, San Francisco
Start date: 2004-08-01; Completion date: 2011-03-01
Enrollment: 66 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The patients eligible for this study are those diagnosed with glioblastoma or gliosarcoma who have recently undergone surgery and who have not been treated with radiation therapy or chemotherapy. This is called a phase II study. The purpose of the phase II study is to determine how effective Tarceva plus Temodar plus radiation is in controlling the growth of glioblastoma and gliosarcoma. All patients will receive radiation and Temodar plus Tarceva. There is no "placebo" drug.

Detailed description:
This is a Phase II Study of Tarceva plus Temodar during and following radiation therapy in patients with newly diagnosed glioblastoma multiforme and gliosarcoma. The efficacy and safety profile of Tarceva in combination with radiation therapy plus Temodar will be studied. In addition, correlations between response to treatment and epidermal growth factor receptor (EGFR) status as well as other molecular markers of tumor prior to treatment will be explored. Patients will be stratified according to enzyme inducing anti epileptic drug (EIAED) use. Group A (not on EIAEDs) will take 100 milligrams (mg) Tarceva/day during radiotherapy and start with a dose of 150 mg Tarceva/day two weeks after radiotherapy. Group B (on EIAEDs) will take 200mg Tarceva/day during radiotherapy and start with a dose of 300 mg Tarceva/day two weeks after radiotherapy. Both groups will take 75 mg/m\^2 Temodar/day during radiotherapy and 200 mg/m\^2 Temodar/day x 5 two weeks after radiotherapy. Intrapatient Tarceva dose escalation may occur every two weeks after radiotherapy until the appearance of a particular rash severity. The maximum dose allowed is 200 mg for group A and 500 mg for group B.

Arms: arm 1: Single arm phase-2 experimental treatment of newly diagnosed patients with Glioblastoma with Temodar plus Tarceva plus Radiation Therapy
Interventions: intervention 1: Tarceva intervention 2: Temodar intervention 3: Radiation Therapy
Intervention descriptions: intervention 1: Tarceva (erlotinib hydrochloride; previously referred to as OSI-774), a quinazoline, is an orally active, potent, selective inhibitor of EGFR tyrosine kinase. 100 - 300 milligrams (mg) every day (QD) orally (PO) every (q) 28 days depending on EIAED Status intervention 2: Temodar 200 mg/m\^2/day x 5 days every 28 days intervention 3: Radiotherapy will be administered in 180 centigray(cGy)/day - 200cGy/day fractions delivered 5 days per week to a total dose of 5940cGy - 6100cGy. A total of 4500cGy will be delivered to the clinical tumor volume consisting of T2-bright edema + a 2centimeter margin, or, if no edema, the contrast enhancing lesion +2.5 centimeter margin. An additional boost of 1440cGy will be delivered to the gross tumor volume consisting of the contrast enhancing lesion + a 1 centimeter margin.

Protocol documents:
Clinical trial NCT00203411
Conditions: Colorectal Cancer
Sponsor: Translational Oncology Research International
Start date: 2006-03-01; Completion date: 2011-03-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and effectiveness of the bevacizumab and capecitabine combination in frail patients with untreated metastatic colorectal cancer.

Detailed description:
The study will evaluate the tolerability, safety, and feasibility of combination bevacizumab and capecitabine in a small number of frail patients with metastatic colorectal cancer who have a compromised performance status. Preclinical studies suggest that the combination of chemotherapy and anti-angiogenic therapy offer an increased anti-tumor effect compared with either treatment alone.

Arms: arm 1: Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m\^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
Interventions: intervention 1: Capecitabine (Xeloda) intervention 2: Bevacizumab
Intervention descriptions: intervention 1: 1000mg/m\^2 administered orally twice daily for two weeks followed by one week rest period intervention 2: 7.5 mg/kg IV will be administered every 3 weeks

Protocol documents:
Clinical trial NCT00237458
Conditions: Chronic Refractory Neuropathic Pain
Sponsor: UCB Pharma
Start date: 2001-05-01; Completion date: 2011-03-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is the follow-on trial to a preceeding open-label trial which included patients with chronic refractory neuropathic pain. It is conducted at one site in the United Kingdom and the patient enrollment is completed. The patients had successfully completed the above mentioned trial and, in the investigator's opinion, would benefit from long-term administration of Lacosamide. After a 1-week run-in phase the patients were uptitrated to their optimal dose and then continued into the maintenance phase. Different pain qualities are assessed by a patient's diary.

Detailed description:

Arms: arm 1: Open-label active treatment
Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: Dosage: Lacosamide up to 400 mg/day;

Dosage form: Film-coated tablets;

Dosage Frequency and Duration: Two times per day; 9.5 years

Protocol documents:
Clinical trial NCT00243022
Conditions: Brain and Central Nervous System Tumors Cerebral Edema
Keywords: cerebral edema adult glioblastoma adult giant cell glioblastoma adult gliosarcoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma
Sponsor: Ali Altunkaya
Start date: 2004-09-01; Completion date: 2011-03-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Giving the herb Boswellia serrata after surgery and radiation therapy may slow the growth of any remaining tumor cells. It is not yet known whether giving Boswellia serrata together with standard treatment is more effective than standard treatment alone in treating high-grade gliomas.

PURPOSE: This randomized phase II trial is the study of a combination of complementary and alternative medicine (CAM) herbal supplement intervention as an adjuvant to standard treatment of patients with newly diagnosed and recurrent high-grade gliomas (HGG). The central hypothesis of this application is that a herbal preparation that inhibits 5-LO activity, will produce measurable biologically meaningful decrease in 5-LO eicosanoid production and brain edema that will be associated with improved survival and quality of life in patients with HGG.

Detailed description:
OBJECTIVES:

Primary

* To determine whether a herbal approach to decreasing 5-LO eicosanoid production reduces peritumoral brain edema in patients with HGG.

Secondary

* To determine if this adjuvant approach improves the quality of life and progression free and overall survival of patients with HGG.

OUTLINE: This a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.

* Arm I (intervention): Patients receive oral Boswellia serrata herbal extract 4 times a day and oral cyanocobalamin (vitamin B-12) once a day for 6 months in the absence of unacceptable toxicity.
* Arm II (control): Patients receive oral vitamin B-12 once a day for 6 months. All patients are encouraged to eat a regular balanced diet (as recommended by the American Cancer Society for cancer prevention) with limited consumption of red and processed meats.

Quality of life will be assessed at baseline and then at 2, 4, 6, 12, and 24 months.

After completion of study treatment, patients will be followed every 6 months.

PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study.

Arms: arm 1: Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity. arm 2: Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
Interventions: intervention 1: Boswellia serrata extract intervention 2: cyanocobalamin
Intervention descriptions: intervention 1: given orally intervention 2: given orally

Protocol documents:
Clinical trial NCT00278876
Conditions: Sarcoma Gastrointestinal Stromal Tumors
Keywords: GIST Imatinib Adjuvant therapy Kit mutation
Sponsor: Asan Medical Center
Start date: 2005-04-01; Completion date: 2011-03-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The presence of c-kit mutation is an independent poor prognostic factor for relapse in addition to large size (\> 5 cm) and high mitotic rate (\> 5/50 high power field \[HPF\]) in localized gastrointestinal stromal tumor (GIST) patients who underwent complete surgical resection. In addition, the localized GIST which had exon 11 c-kit mutation and features of high-risk for relapse according to National Institute of Health (NIH) consensus guideline (tumor size \> 10 cm or mitotic count \> 10/50 HPF) also have high-risk of relapse. Until recently, there has been no effective therapy for advanced, unresectable GISTs. However, a new agent, imatinib mesylate, has shown promise in the metastatic setting, and c-kit exon 11 mutation is the strongest prognostic factor for better response and survival. It is reasonable to try imatinib in an earlier and minimal residual status especially for patients at higher risk of relapse and a higher probability of response to imatinib.

Detailed description:

Arms: arm 1: patients receiving adjuvant imatinib mesylate
Interventions: intervention 1: Imatinib mesylate (Glivec)
Intervention descriptions: intervention 1: Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks

Protocol documents:
Clinical trial NCT00281528
Conditions: Breast Neoplasms Neoplasm Metastasis
Keywords: First Line Metastatic Breast Cancer
Sponsor: Celgene
Start date: 2006-02-01; Completion date: 2011-03-01
Enrollment: 208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, open-label, randomized Phase II study in previously untreated patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly infusion. All patients will also receive concurrent bevacizumab.

Detailed description:

Arms: arm 1: 260 mg/m\^2 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks arm 2: 260 mg/m\^2 ABI-007 every 2 weeks and 10 mg/kg bevacizumab every 2 weeks arm 3: 130 mg/m\^2 ABI-007 weekly (without a week of 'rest') and 10 mg/kg bevacizumab every 2 weeks
Interventions: intervention 1: ABI-007 (Abraxane) intervention 2: bevacizumab
Intervention descriptions: intervention 1: 30 minute infusions intervention 2: infusions

Protocol documents:
Clinical trial NCT00303862
Conditions: Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage IV Renal Cell Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-03-01; Completion date: 2011-03-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well AZD2171 works in treating patients with refractory metastatic kidney cancer. AZD2171 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. Determine the objective response rate in patients with refractory metastatic renal cell carcinoma treated with AZD2171.

SECONDARY OBJECTIVES:

I. Determine the safety and tolerability of AZD2171 in these patients. II. Determine the feasibility of performing standardized delayed contrast-enhancement-MRI correlative studies across different institutions and platforms with data-sharing capability in patients with metastatic renal cell cancer.

III. Generate preliminary data regarding potential utility of pharmacogenomic and plasma/serum biomarkers of angiogenesis as predictive or prognostic markers for future investigations of AZD2171 and renal cell carcinoma.

OUTLINE: This is a multicenter study.

Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 6 weeks.

Arms: arm 1: Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cediranib maleate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00323739
Conditions: Kidney Cancer
Keywords: kidney cancer bevacizumab
Sponsor: SCRI Development Innovations, LLC
Start date: 2006-05-01; Completion date: 2011-03-01
Enrollment: 80 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial will evaluate the combination of bevacizumab + RAD001 in patients with metastatic renal cell carcinoma. In this trial the investigators will evaluate this combination in patients previously untreated with any anti-angiogenesis agent and patients who have previously received one prior regimen containing an anti-angiogenesis agent.

Detailed description:
All eligible patients will receive:

* Bevacizumab 10mg/kg, IV infusion, every 2 weeks
* RAD001 10 mg by mouth daily

All patients will be evaluated for response after completing two courses (8 weeks) of treatment. Patients with objective tumor response or stable disease will continue treatment with bevacizumab adn RAD001 on the same schedule. Treatment will continue until disease progression occurs.

Arms: arm 1: Bevacizumab 10mg/kg, IV infusion, every 2 weeks RAD001 10 mg by mouth daily
Interventions: intervention 1: bevacizumab intervention 2: RAD001
Intervention descriptions: intervention 1: Bevacizumab 10mg/kg, IV infusion, every 2 weeks intervention 2: RAD001 10 mg by mouth daily

Protocol documents:
Clinical trial NCT00359762
Conditions: Type 2 Diabetes Mellitus
Keywords: exenatide diabetes Amylin Lilly glimepiride
Sponsor: AstraZeneca
Start date: 2006-09-01; Completion date: 2011-03-01
Enrollment: 1029 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exenatide intervention 2: glimepiride
Intervention descriptions: intervention 1: subcutaneous injection (5mcg or 10mcg), twice a day intervention 2: oral tablet (titrated to maximally tolerated dose), once daily

Protocol documents:
Clinical trial NCT00366106
Conditions: Multiple Myeloma
Keywords: Relapsed Multiple Myeloma Refractory Multiple Myeloma
Sponsor: Accelerated Community Oncology Research Network
Start date: 2006-07-01; Completion date: 2011-03-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The current study is being conducted to evaluate the possibility that a different schedule of bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib dosing for a longer period.

Detailed description:

Interventions: intervention 1: bortezomib intervention 2: dexamethasone intervention 3: doxorubicin HCl liposome
Intervention descriptions: intervention 1: Patients will be treated with bortezomib at 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days (cycle). intervention 2: Dexamethasone tablets will be given at 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days (cycle). intervention 3: Patients will receive intravenous doxorubicin HCl liposome injection given at 30 mg/m\^2 on Day 4 every 28 days (cycle).

Protocol documents:
Clinical trial NCT00371150
Conditions: Hepatitis B Infection
Sponsor: Bristol-Myers Squibb
Start date: 2006-11-01; Completion date: 2011-03-01
Enrollment: 131 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical research study is to develop observational clinical experience with the use of entecavir in participants who are either of Black/African-American race or of Hispanic ethnicity.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Entecavir
Intervention descriptions: intervention 1: Tablets, Oral, 0.5 mg, once daily, up to 52 weeks

Protocol documents: