ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00075400
Conditions: Recurrent Uterine Sarcoma Uterine Carcinosarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2004-01-01; Completion date: 2010-07-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II clinical trial studies the side effects and how well imatinib mesylate works in treating patients with uterine cancer that has failed to respond to initial chemotherapy or has re-grown after therapy. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the activity of Gleevec\^trademark (TM) (imatinib mesylate) as measured by progression-free survival at six months.

II. To determine the frequency and severity of adverse effects of Gleevec\^TM in this cohort of patients as assessed by the Common Terminology Criteria of Adverse Events version 3.0 (CTCAE v3.0).

SECONDARY OBJECTIVES:

I. To determine the distribution of progression-free survival and overall survival.

II. To estimate the objective response rate (partial and complete response as defined under the Response Evaluation Criteria In Solid Tumors \[RECIST\] criteria).

III. To determine the effects of prognostic factors such as initial performance status and histological grade.

TERTIARY OBJECTIVES:

I. To determine the levels of expression of v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (c-KIT), platelet-derived growth factor receptor (PDGFR), v-akt murine thymoma viral oncogene homolog 2 (AKT2), and phosphorylated (p)-AKT2 in archived, formalin-fixed, paraffin-embedded primary tumors collected prior to the initiation of first-line chemotherapy

OUTLINE:

Patients receive imatinib mesylate orally (PO) once daily (QD) or twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: Patients receive imatinib mesylate PO QD or BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: imatinib mesylate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00088530
Conditions: Lymphoma, Non-Hodgkin
Keywords: Pixantrone Non-Hodgkins lymphoma
Sponsor: CTI BioPharma
Start date: 2004-07-01; Completion date: 2010-07-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).

Detailed description:
The primary study objective is to compare the efficacy of BBR 2778 to a selection of single agents. Secondary objectives are to compare the safety and tolerability of BBR 2778 to a selection of single agents, and to assess the pharmacokinetic parameters of BBR 2778 in a subset of this patient population.

Arms: arm 1: Pixantrone (BBR2778) arm 2: To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone
Interventions: intervention 1: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone intervention 2: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
Intervention descriptions: intervention 1: Day 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day) intervention 2: Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)

Protocol documents:
Clinical trial NCT00096486
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2004-05-01; Completion date: 2010-07-01
Enrollment: 74 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Gefitinib and everolimus may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving gefitinib together with everolimus may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects, best way to give, and best dose of giving gefitinib with everolimus and to see how well it works in treating patients with stage IIIB or stage IV or recurrent non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the maximum tolerated dose of everolimus when administered with gefitinib in patients with stage IIIB or IV or recurrent non-small cell lung cancer. (Phase I)
* Determine the efficacy of this regimen in these patients. (Phase II)

Secondary

* Assess the pharmacokinetics of everolimus, alone and in combination with gefitinib, in these patients. (Phase I)

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

* Phase I: Patients receive oral everolimus once on day 1. Beginning on day 8, patients receive oral gefitinib once daily. Beginning on day 22, patients receive oral everolimus once daily. Both drugs are then given concurrently for the rest of the treatment. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of everolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

* Phase II: Patients receive oral everolimus at the MTD determined in phase I and oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Phase I: Patients receive oral everolimus once on day 1. Beginning on day 8, patients receive oral gefitinib once daily. Beginning on day 22, patients receive oral everolimus once daily. Both drugs are then given concurrently for the rest of the treatment. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of everolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

* Phase II: Patients receive oral everolimus at the MTD determined in phase I and oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: everolimus intervention 2: gefitinib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00112489
Conditions: Sarcoma
Keywords: recurrent uterine sarcoma stage III uterine sarcoma stage IV uterine sarcoma uterine carcinosarcoma
Sponsor: Gynecologic Oncology Group
Start date: 2005-05-01; Completion date: 2010-07-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.

Detailed description:
OBJECTIVES:

* Determine the antitumor activity of paclitaxel and carboplatin in patients with persistent or recurrent stage III or IV uterine carcinosarcoma.
* Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: Approximately 14-47 patients will be accrued for this study within 20 months.

Arms: arm 1: Paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC = 6 IV over 30 minutes every 21 days until disease progression or adverse effects prohibit further therapy
Interventions: intervention 1: carboplatin intervention 2: paclitaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00114127
Conditions: Anxiety Disorder
Keywords: social anxiety disorder social phobia duloxetine serotonin norepinephrine reuptake inhibitor SNRI double blind
Sponsor: Massachusetts General Hospital
Start date: 2004-06-01; Completion date: 2010-07-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the safety and efficacy of duloxetine for the treatment of social anxiety disorder.

Detailed description:
An expanding body of clinical experience and controlled trials has established the efficacy of serotonin selective reuptake inhibitors (SSRIs) and the serotonin norepinephrine reuptake inhibitor (SNRI) venlafaxine, for the treatment of social anxiety disorder, with paroxetine, sertraline and venlafaxine extended-release (XR), which are FDA approved for this indication. The newest SNRI, duloxetine, has been shown to be effective at doses of 60mg/day to 120mg/day for anxiety associated with depression, and is anticipated to be a broad spectrum agent for mood and anxiety disorders (Dunner, Goldstein, Mallinckrodt, Lu, \& Detke, 2003). However, no data on the efficacy of duloxetine for Social Anxiety Disorder, nor guidance regarding time to response or predictors of response, is yet available. These questions are the focus of this proposal.

This is a two phase, 24-week research study in which participants who remain symptomatic at the end of one phase (6 weeks) enter into the next phase. In phase I, all participants receive 60mg/day of duloxetine (Cymbalta) for 6 weeks. Participants who continue to have anxiety symptoms will enter the 18-week Phase II, in which they continue taking 60 mg/day of duloxetine and they will also be randomly assigned (by chance, like a flip of a coin) to receive either an additional 60mg/day of duloxetine or placebo (contains no active medication).

Arms: arm 1: In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine. arm 2: In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine. arm 3: In Phase 1 all participants entered an open trial.
Interventions: intervention 1: Duloxetine intervention 2: Duloxetine intervention 3: Placebo
Intervention descriptions: intervention 1: 60 mg duloxetine 1x per day intervention 2: 60 mg duloxetine 1x per day + 60mg duloxetine 1x per day intervention 3: 60mg placebo 1x per day

Protocol documents:
Clinical trial NCT00114218
Conditions: Recurrent Uterine Corpus Sarcoma Uterine Carcinosarcoma
Sponsor: Gynecologic Oncology Group
Start date: 2005-03-01; Completion date: 2010-07-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Detailed description:
OBJECTIVES:

I. Determine the antitumor activity of gemcitabine and docetaxel in patients with recurrent or persistent uterine carcinosarcoma.

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

OUTLINE: This is a non-randomized, multicenter study. Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, 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 1-4 years.

Arms: arm 1: Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Interventions: intervention 1: Gemcitabine Hydrochloride intervention 2: Docetaxel
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents:
Clinical trial NCT00130923
Conditions: Schizophrenia Psychotic Disorders Substance Abuse Alcohol Abuse
Keywords: Risperidone Schizophrenia Substance Use Disorder Alcohol Use Disorder Treatment Schizoaffective Disorder
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2005-09-01; Completion date: 2010-07-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffective disorder.

Detailed description:
Comorbid alcohol/substance use disorder (SUD) in people with schizophrenia is a major concern, both in view of the high frequency of SUD among patients with schizophrenia and the difficulty in managing such patients. Though antipsychotic medications are effective in reducing symptoms and impairment in persons with schizophrenia, the typical antipsychotic agents are of limited value in controlling alcohol/substance use in these patients. Extrapyramidal, dysphoric side effects of conventional neuroleptics may actually promote the use of substances in an attempt to counteract these effects. In addition, medication non-compliance is common among patients with schizophrenia.

Novel antipsychotics have altered treatment expectations and outcomes for patients with severe forms of schizophrenia. A growing number of studies have assessed the effects of oral risperidone in persons with dual disorders. Potential mechanisms of action by which risperidone and other atypical antipsychotics could decrease substance use include being less likely to cause extrapyramidal side effects than typical agents, improving negative symptoms and ameliorating a dysfunction of the brain reward system. Risperidone long-acting injectable medication addresses issues of noncompliance, while avoiding peak blood levels of oral preparations, thereby minimizing EPS and improving negative symptoms of schizophrenia. Risperidone may also facilitate dopamine neurotransmission in the prefrontal cortex and correct a hypothesized dysfunction of the brain reward system.

This study is an open, randomized, controlled study to compare intramuscular long-acting risperidone to oral risperidone with blinded ratings to determine whether the long-acting form of risperidone has greater efficacy in reducing substance use. Patients with schizophrenia or schizoaffective disorder, age 18 to 65, who are taking any single oral antipsychotic medication except clozapine or risperidone long-acting may be enrolled.

Arms: arm 1: Risperidone Long Acting; aka Risperdal Consta; injectable form arm 2: Oral Risperidone; aka Risperdal; oral form
Interventions: intervention 1: Risperidone Long Acting intervention 2: oral risperidone
Intervention descriptions: intervention 1: Dose 25.00, 37.50 or 50.00 mg q two weeks intervention 2: 0.50-6.00 mg oral risperidone daily

Protocol documents:
Clinical trial NCT00184028
Conditions: Carcinoma of the Head and Neck
Sponsor: University of Southern California
Start date: 2004-09-01; Completion date: 2010-07-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This research study is for subjects with squamous cell cancer of the head and neck which is not solely treatable with surgery or radiation. This research study involves treatment with an experimental chemotherapy combination of oxaliplatin and Taxotere. Tha main purpose of this study is to assess the effectiveness of this combination of medications for this type of cancer.

Approximately 54 subjects will take part in this study.

Detailed description:

Arms: arm 1: On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
Interventions: intervention 1: Taxotere intervention 2: Oxaliplatin
Intervention descriptions: intervention 1: Taxotere is given at 60 mg/m2 as a 1-hour intravenous infusion. intervention 2: Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min. on day 1 every 3 weeks.

Protocol documents:
Clinical trial NCT00193219
Conditions: Colon Cancer
Keywords: Colon Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2005-07-01; Completion date: 2010-07-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin, oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of advanced colorectal cancer. The role of epidermal growth factor (EGFR) inhibitors in an earlier treatment setting in combination with optimal chemotherapy regimens is an important emerging question.

Detailed description:
All patients received cetuximab: 400 mg/m2 (first cycle only) administered intravenously (IV) on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8. Day 1 cetuximab was immediately followed by bevacizumab 5 mg/kg IV, oxaliplatin 85 mg/m2 IV, and 5-fluorouracil 400 mg/m2 IV bolus, followed by 2400 mg/m2 administered as a continuous infusion over 46 hours via a pump (outpatient) and leucovorin 350 mg IV (modified FOLFOX6). Cycles were 14 days.

Arms: arm 1: Bevacizumab 5 mg/kg IV

Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8

5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient)

Leucovorin 350 mg IV

Oxaliplatin 85 mg/m2 IV
Interventions: intervention 1: Bevacizumab intervention 2: Cetuximab intervention 3: 5-fluorouracil intervention 4: Leucovorin intervention 5: Oxaliplatin
Intervention descriptions: intervention 1: 5 mg/kg IV intervention 2: 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 intervention 3: 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) intervention 4: 350 mg IV intervention 5: 85 mg/m2 IV

Protocol documents:
Clinical trial NCT00218387
Conditions: Cocaine Dependence
Keywords: Cocaine Dependence
Sponsor: Medical University of South Carolina
Start date: 2004-04-01; Completion date: 2010-07-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Modafinil, a medication that enhances mood, increases energy, and improves concentration, may be useful in preventing relapse among individuals with cocaine addiction. This study will evaluate the effectiveness of modafinil, in combination with cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.

Detailed description:
The development of a medication to treat cocaine addiction specifically by lessening withdrawal symptoms has been a primary focus of research. Common cocaine withdrawal symptoms include depression, lack of energy, and poor concentration. Modafinil, a central nervous system stimulant, is a medication that can speed up physical and mental processes in the brain. It is currently used to treat narcolepsy, a condition that causes excessive sleepiness. Modafinil enhances mood, increases energy, and improves concentration in people with narcolepsy. Modafinil may also cause the same effects in individuals addicted to cocaine, thereby countering the symptoms of cocaine withdrawal. The purpose of this study is to compare the effectiveness of modafinil plus CBT versus placebo plus CBT for treating cocaine dependence.

A 2-week screening period will be followed by an 8-week treatment phase. Participants will be randomly assigned to receive either 200 mg of modafinil, 400 mg of modafinil, or placebo on a daily basis for the 8 weeks of treatment. During this time, participants will be asked to report the number of days that they use and do not use cocaine. This will be confirmed three times a week with urine tests. Mood, level of daytime sleepiness, and symptoms of cocaine withdrawal and cocaine "high" will be evaluated. Compliance with study medication will be assessed with urine and blood tests. Medication side effects will be monitored through physical examinations, routine lab tests, ECGs, and self-reports. Follow-up evaluations will occur 4 and 8 weeks following the end of treatment.

Arms: arm 1: 200mg Modafinil arm 2: 400mg Modafinil arm 3: Matching Placebo
Interventions: intervention 1: Modafinil intervention 2: Modafinil intervention 3: Matching Placebo
Intervention descriptions: intervention 1: 200mg Modafinil intervention 2: 400mg Modafinil intervention 3: Matching Placebo

Protocol documents:
Clinical trial NCT00221195
Conditions: Hemophilia A With Inhibitors
Sponsor: Tulane University School of Medicine
Start date: 2003-06-01; Completion date: 2010-07-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patients with hemophilia and persistent high responding inhibitors.

Detailed description:

Arms: arm 1: Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug arm 2: Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
Interventions: intervention 1: activated prothrombin complex concentrate (FEIBA)
Intervention descriptions: intervention 1: FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months

FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months

Protocol documents: