ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00238615
Conditions: Lung Cancer Carcinoma, Non-Small-Cell Lung
Sponsor: Stanford University
Start date: 2003-03-01; Completion date: 2014-11-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.

Detailed description:

Arms: arm 1: 1. Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy.
2. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy.
3. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation
4. Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
Interventions: intervention 1: Docetaxel intervention 2: Carboplatin intervention 3: Radiation therapy intervention 4: Surgical resection
Intervention descriptions: intervention 1: 20 mg/m2, 75 mg/m2 infusion intervention 2: AUC of 2 and 6 infusion intervention 3: NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period. intervention 4: All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.

Protocol documents:
Clinical trial NCT00257608
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC Lung Cancer ATLAS Avastin Tarceva
Sponsor: Genentech, Inc.
Start date: 2006-01-01; Completion date: 2014-11-01
Enrollment: 1145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bevacizumab intervention 2: placebo intervention 3: erlotinib HCl
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: Oral repeating dose intervention 3: Oral repeating dose

Protocol documents:
Clinical trial NCT00387465
Conditions: Recurrent Non-Small Cell Lung Carcinoma Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer Stage IV Non-Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-08-01; Completion date: 2014-11-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial is studying the side effects and best dose of azacitidine when given together with entinostat and to see how well they work in treating patients with recurrent advanced non-small cell lung cancer. Azacitidine and entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess safety, characterize toxicities, and determine the maximum tolerated dose of 5-AZA (azacitidine) with a fixed-dose of entinostat in patients with recurrent advanced non-small cell lung cancer (NSCLC). (Phase I) II. To determine the objective response rate of 5-AZA and entinostat in patients with recurrent NSCLC. (Phase II)

SECONDARY OBJECTIVES:

I. To determine the pharmacokinetic profile of 5-AZA and entinostat in patients with recurrent NSCLC.

II. To assess the pharmacodynamic effects of 5-AZA and entinostat on deoxyribonucleic acid (DNA) methylation, histone acetylation, and gene re-expression in patients with recurrent NSCLC through analysis of blood, sputum and tissue biopsies.

III. To explore the effect of 5-AZA and entinostat on progression-free and overall survival in patients with recurrent advanced non-small cell lung cancer.

IV. To explore the differing response rates and progression-free survivals of two schedules of 5-AZA and entinostat in patients with recurrent advanced non-small cell lung cancer.

OUTLINE: This is a multicenter, phase I, dose-escalation study of azacitidine followed by an open-label, phase II study.

Patients receive azacitidine subcutaneously (SC) on days 1-6 and 8-10 and entinostat orally (PO) on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Arms: arm 1: Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle. arm 2: Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle. arm 3: Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Azacitidine 30mg/m2 intervention 2: Entinostat intervention 3: Azacitidine 40mg/m2
Intervention descriptions: intervention 1: Azacitidine 30mg/m2 subcutaneously (SQ) intervention 2: 7mg by mouth (PO) on days 3 and 10 of each cycle intervention 3: Azacitidine 40mg/m2 SQ

Protocol documents:
Clinical trial NCT00393861
Conditions: Neoplasms, Germ Cell and Embryonal
Keywords: Germ Cell Tumor Germ Cell Cancer
Sponsor: Indiana University
Start date: 2006-10-01; Completion date: 2014-11-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness of oxaliplatin and bevacizumab in patients with refractory or relapsed germ cell tumors.

Detailed description:
This study proposes to look at the established combination of oxaliplatin and bevacizumab as used in colorectal cancer in refractory germ cell tumor patients. Oxaliplatin is a drug of known activity. Although bevacizumab has no single agent data, it combines dramatically well with numerous chemotherapy drugs, such as oxaliplatin increasing response rates and improving survival. Furthermore, VEG-F appears to be an important target in germ cell tumors as it does in so many other types of solid tumors. We will be using the identical dosages of oxaliplatin + bevacizumab as has been utilized in previously treated colorectal cancer, without the addition of 5-FU + leucovorin. This dose and schedule has been proven to be safe and effective.

Arms: arm 1: None
Interventions: intervention 1: Bevacizumab and Oxaliplatin
Intervention descriptions: intervention 1: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes

Protocol documents:
Clinical trial NCT00404924
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: Non-Small-Cell Lung Carcinoma Adenocarcinoma Squamous Cell Carcinoma Large Cell Carcinoma
Sponsor: Genzyme, a Sanofi Company
Start date: 2006-11-01; Completion date: 2014-11-01
Enrollment: 1140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is more effective than best supportive care alone, for the treatment of patients with non-small cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug in development that works in a different way to standard chemotherapy drugs. It targets the growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour may take to progress to a further stage. Approximately 930 patients will take part in this study. It will be conducted in hospitals and clinics in North and South America, Europe and Asia.

Detailed description:

Arms: arm 1: Best Supportive Care arm 2: Vandetanib + Best Supportive Care
Interventions: intervention 1: ZD6474 (vandetanib) intervention 2: Best Supportive Care
Intervention descriptions: intervention 1: once daily oral tablet intervention 2: standard of care

Protocol documents:
Clinical trial NCT00413478
Conditions: Chronic Lymphocytic Leukemia Leukemia
Keywords: 5-Aza Azacytidine Vidaza CLL Chronic Lymphocytic Leukemia Richter's transformation Leukemia
Sponsor: M.D. Anderson Cancer Center
Start date: 2006-09-01; Completion date: 2014-11-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and T-cell prolymphocytic leukemia (T-PLL).

Detailed description:
Azacytidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have blood drawn (about 3 teaspoons) to check your kidney and liver function (routine blood tests). You may have a bone marrow aspiration performed (if you have not had one in recent weeks). To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative urine pregnancy test.

If you agree to take part in this study, you will receive azacytidine by subcutaneous (just under the skin) injection every day for 7 days. This course of treatment will be repeated every 3-8 weeks, depending on the results of your routine blood tests.

Your doctor may increase or decrease your dose of azacytidine, depending on if you experience any side effects. You will continue to receive treatment on this study unless the disease gets worse or you experience any intolerable side effects. If the disease gets worse or you experience any intolerable side effects, you will be taken off this study.

This is an investigational study. This is an investigational study. Azacytidine has been approved by the FDA for the treatment of myelodysplastic syndrome. Up to 37 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: 5-Azacytidine 75mg/m\^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.
Interventions: intervention 1: 5-Azacytidine
Intervention descriptions: intervention 1: Starting dose level: 75mg/m\^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.

Protocol documents:
Clinical trial NCT00571493
Conditions: Non-hodgkin's Lymphoma Mantle Cell Lymphoma
Keywords: non-hodgkin's lymphoma mantle cell lymphoma BEAM Velcade
Sponsor: University of Nebraska
Start date: 2006-04-14; Completion date: 2014-11-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase I/II trial designed to study the toxicity and Maximum Tolerated Dose (MTD) of bortezomib in combination with BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) and autologous hematopoietic stem cell transplantation (ASCT) and to obtain a preliminary estimate of the response rate to this combination.

Detailed description:
Primary Objective:The primary objective of the study is to evaluate the toxicity and determine the maximum tolerated dose (MTD) of bortezomib when added to a standard BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) conditioning regimen followed by autologous hematopoietic stem cell transplantation (ASCT).

Secondary Objective: The secondary objective of the study is to obtain a preliminary estimate of the overall response rate (ORR), progression free survival (PFS), and overall survival (OS) with this regimen.

Enrolled subjects will receive bortezomib in combination with BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) and autologous hematopoietic stem cell transplantation (AHSCT). Phase I treatment will administer bortezomib in four dose cohorts,in addition to the BEAM and ASCT. Three patients will be accrued in each dose cohort with enrollment starting at dose cohort. These subjects will be evaluated to establish the maximum tolerated dose of bortezomib in combination with BEAM autologous peripheral blood stem cell transplantation. Once established, the maximum tolerated dose will be utilized in treating an additional 20 subjects.

Follow-Up: Data collected will be utilized to obtain a preliminary estimate of the overall response rate, progressions free survival and overall survival using this regimen.

Arms: arm 1: The phase I section of the study will follow a standard 3 + 3 design to determine the maximum tolerated dose (MTD) of bortezomib when added to a standard BEAM (BCNU (carmustine), etoposide, cytarabine, melphalan) conditioning regimen followed by autologous hematopoietic stem cell transplantation (ASCT).

After the MTD is defined, additional patients will enroll in Phase II to obtain preliminary estimates of survival using the Phase I regimen.
Interventions: intervention 1: Bortezomib intervention 2: BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)
Intervention descriptions: intervention 1: Patients will receive bortezomib in four dose cohorts ( .8. 1.0, 1.3, 1.5 mg/m²). Patients will receive bortezomib on days -11, -8, -5, and -2 before infusion of autologous stem cells. intervention 2: All study patients will receive BEAM per the standard institution protocol:

BCNU (carmustine): 300 mg/m²on day -5 etoposide 100 mg/m² twice daily on days -5, -4, -3, and -2 cytarabine 100 mg/m² twice daily on days -5, -4, -3, -2 melphalan: 140 mg/m² on day -1 before infusion of autologous stem cells.

Protocol documents:
Clinical trial NCT00588237
Conditions: Ovarian Cancer Primary PERITONEUM Fallopian Tube Cancer
Keywords: ovary BEVACIZUMAB CISPLATIN TAXOL
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2006-08-01; Completion date: 2014-11-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test whether it is safe to treat your cancer with 3 drugs instead of 2 drugs. After surgery, your cancer is typically treated with 2 drugs called cisplatin and paclitaxel (also known as Taxol). Cisplatin is given through a port in your belly, and Taxol is given both through the belly port and through the vein (IV). Large clinical studies have shown that this treatment gives the best results for women with your cancer. This treatment, however, also causes many side effects, especially belly pain, nerve injury, lowering of the immune system, and infection risk. In the study you are being asked to join, the dose of Cisplatin will be lower in order to try to lessen these problems. This study will also test the safety of adding a 3rd drug called bevacizumab (also known as Avastin). This drug has been shown to shrink ovarian, peritoneal, or fallopian tube cancer in some patients who have advanced disease, despite having received prior treatment for their cancer. Therefore, it may also be effective in patients, like you, who have a new diagnosis.

Unfortunately, Avastin can cause some dangerous side effects in women with advanced cancer. For instance, it can cause a hole in the intestines, and can increase the risk of blood clots and strokes. Avastin has not been given at the same time as IP therapy, so it is not known if this is a safe or effective combination. In this study, IV Avastin will be given in addition to IP cisplatin, IP Taxol, and IV Taxol, to patients like you who have not had any chemotherapy before. This study aims to find out what effects, good and/or bad, that this combination of drugs has on your body and on your type of cancer.

Detailed description:

Arms: arm 1: Paclitaxel, Cisplatin, Bevacizumab
Interventions: intervention 1: Paclitaxel,Cisplatin, Bevacizumab
Intervention descriptions: intervention 1: IV paclitaxel, followed by IV Bevacizumab on Day 1. Bevacizumab treatment will begin cycle 2, day 1. IP cisplatin will be given on Day 2, and IP Paclitaxel on Day 8. Subjects will receive up to six cycles of therapy, or until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00609804
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer Advanced Erlotinib Sorafenib Progressing on erlotinib
Sponsor: SCRI Development Innovations, LLC
Start date: 2008-03-01; Completion date: 2014-11-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone.

Detailed description:

Arms: arm 1: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth arm 2: Sorafenib 400 mg twice daily by mouth.
Interventions: intervention 1: Sorafenib intervention 2: Erlotinib
Intervention descriptions: intervention 1: Sorafenib 400 mg twice daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs. intervention 2: Erlotinib 150 mg once daily by mouth

Protocol documents:
Clinical trial NCT00642616
Conditions: Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Moderate Chronic Obstructive Pulmonary Disease Asthma
Sponsor: Mannkind Corporation
Start date: 2009-03-01; Completion date: 2014-11-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function \& pulmonary safety

Detailed description:

Arms: arm 1: Technosphere® Insulin Inhalation Powder administered prandially in diabetic participants with Asthma arm 2: Usual anti diabetic care in Diabetic participants with Asthma arm 3: Technosphere® Insulin Inhalation Powder administered prandially in diabetic participants with Chronic Obstructive Pulmonary disease (COPD) arm 4: Usual anti diabetic care in Diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
Interventions: intervention 1: Technosphere® Insulin intervention 2: Usual Care
Intervention descriptions: intervention 1: Technosphere® Insulin delivered with Gen 2 inhaler with doses individualized for each participant in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents intervention 2: Type 1 diabetics: long-acting (basal) insulin plus rapid-acting insulin, or pre-mix insulin Type 2 diabetics: oral anti-diabetic medications with or without long-acting (basal) insulin

Protocol documents:
Clinical trial NCT00673894
Conditions: Type 2 Diabetes
Sponsor: Garvan Institute of Medical Research
Start date: 2008-04-01; Completion date: 2014-11-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study investigated the effect of glutamine, an amino acid, glycemia, glucagon-like peptide-1 (GLP-1) and insulin in participants with type 2 diabetes.

Detailed description:
In this study, we investigated the effect of glutamine, an amino acid, on glycemia and on GLP-1 and insulin in participants with type 2 diabetes. Preliminary data published by our group suggests that glutamine is a strong determinant of GLP-1 secretion in vitro. We tested the hypothesis that glutamine lowers postprandial blood glucose and investigated whether the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin modifies this effect.

Arms: arm 1: Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin arm 2: Glutamine 30 g/d (15 g with breakfast and dinner) + placebo
Interventions: intervention 1: Sitagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Glutamine 30g +sitagliptin 100mg intervention 2: Glutamine 30g +placebo (matching sitagliptin 100 mg)

Protocol documents:
Clinical trial NCT00686959
Conditions: Non Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2008-09-01; Completion date: 2014-11-01
Enrollment: 598 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.

Detailed description:

Arms: arm 1: Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles

Concurrent Phase:

Pemetrexed: 500 milligrams per meter squared (mg/m\^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles.

Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray \[Gy\] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.

Consolidation Phase:

Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles arm 2: Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles

Concurrent Phase:

Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36

Consolidation Phase options:

Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
Interventions: intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Etoposide intervention 4: Vinorelbine intervention 5: Paclitaxel intervention 6: Carboplatin intervention 7: Thoracic Radiation Therapy (TRT)
Intervention descriptions: intervention 1: infusion over 10 minutes intervention 2: infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines intervention 3: administered per local practice guidelines over a minimum of 30 minutes intervention 4: administered over 6-10 minutes infusion per local practice guidelines intervention 5: administered as a 3-hour infusion intervention 6: administered per local practice guidelines over 30 minutes intervention 7: None

Protocol documents: