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| Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00010257 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Thymoma and Thymic Carcinoma |
Drug: carboplatin Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma |
| Estimated Enrollment: | 46 |
| Study Start Date: | February 2001 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression. Patients achieving complete or partial remission or stable disease receive 4 additional courses of therapy for a maximum of 6 courses. Further treatment may be given at the discretion of the treating physician.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 35-68 patients will be accrued for this study within 3.8-4.6 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 67 Study Locations| Study Chair: | Patrick J. Loehrer, MD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
| Responsible Party: | ECOG Group Chair's Office ( Robert L. Comis ) |
| Study ID Numbers: | CDR0000068461, ECOG-1C99, NCI-E1C99 |
| Study First Received: | February 2, 2001 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00010257 History of Changes |
| Health Authority: | United States: Federal Government |
|
invasive thymoma and thymic carcinoma recurrent thymoma and thymic carcinoma |
|
Thoracic Neoplasms Paclitaxel Tubulin Modulators Thymoma Thymus Neoplasms Antimitotic Agents |
Carboplatin Antineoplastic Agents, Phytogenic Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
|
Thoracic Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Thymoma Thymus Neoplasms Antineoplastic Agents, Phytogenic Neoplasms, Complex and Mixed Neoplasms, Glandular and Epithelial |