Paclitaxel in Treating Women With Recurrent Solid Tumors
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women who have recurrent solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Primary Purpose: Treatment |
| Official Title: | Prospective Evaluation of Body Surface Area (BSA) as a Determinant of Paclitaxel Pharmacokinetics/Pharmacodynamics in Women With Solid Tumors |
| Enrollment: | 32 |
| Study Start Date: | November 1997 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | January 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Evaluate the relationships between body surface area (BSA) and toxic effects, BSA and pharmacokinetics, and pharmacokinetics and toxic effects in women with recurrent solid tumors who receive a fixed total dose of paclitaxel. II. Determine the toxic effects of paclitaxel in these patients. III. Assess the pharmacokinetics of paclitaxel in these patients.
OUTLINE: Patients receive single fixed dose intravenous paclitaxel over 3 hours on day 1. Blood samples must be drawn prior to the first paclitaxel infusion and then at 1, 6, and 24 hours after the start of the infusion during course 1 only. Treatment courses of intravenous paclitaxel are repeated every 3 weeks at the discretion of the treating physician. Patients are evaluated for response after the second course. Patients are followed at the discretion of the physician.
PROJECTED ACCRUAL: A total of 50 patients will be accrued over 13 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven recurrent adult solid tumors Must have measurable or evaluable disease No known bone marrow metastasis
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Women Performance Status: Zubrod 0-2 Life Expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2.0 times upper limit of normal Renal: Creatinine no greater than 1.5 times upper limit of normal Other: Concurrently active secondary malignancies are allowed
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior paclitaxel therapy No more than 1 prior chemotherapy regimen for metastatic disease At least 4 weeks since chemotherapy Greater than 6 weeks since nitrosoureas, melphalan, or mitomycin Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy No prior whole pelvic radiation Surgery: At least 4 weeks since major surgery
Contacts and Locations
Show 34 Study Locations| Study Chair: | Antonius A. Miller, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
Publications:
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00003130 History of Changes |
| Other Study ID Numbers: | CDR0000065893, U10CA031946, CLB-9763 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 31, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Cancer and Leukemia Group B:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013