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Paclitaxel in Treating Women With Recurrent Solid Tumors

This study has been completed.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: November 1, 1999
Last updated: September 27, 2013
Last verified: September 2013

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

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

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)
Detailed Description:

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.


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
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Please refer to this study by its identifier: NCT00003130

  Show 34 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Study Chair: Antonius A. Miller, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Miller AA, Rosner GL, Egorin MJ, et al.: Prospective evaluation of body surface area (BSA) as a determinant of paclitaxel pharmacokinetics/pharmacodynamics in women with solid tumors (CALGB 9763). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-500, 125, 2003.

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00003130     History of Changes
Other Study ID Numbers: CDR0000065893, U10CA031946, CLB-9763
Study First Received: November 1, 1999
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on November 25, 2014