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Paclitaxel in Treating Women With Recurrent Solid Tumors

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00003130
Collaborator
National Cancer Institute (NCI) (NIH)
32
Enrollment
34
Locations
1
Arm
98
Duration (Months)
0.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Evaluation of Body Surface Area (BSA) as a Determinant of Paclitaxel Pharmacokinetics/Pharmacodynamics in Women With Solid Tumors
Study Start Date :
Nov 1, 1997
Actual Primary Completion Date :
Jan 1, 2002
Actual Study Completion Date :
Jan 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: paclitaxel

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.

Drug: paclitaxel

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 University of California San Diego Cancer Center La Jolla California United States 92093-0658
    2 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94143-0128
    3 CCOP - Christiana Care Health Services Wilmington Delaware United States 19899
    4 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    5 CCOP - Mount Sinai Medical Center Miami Beach Florida United States 33140
    6 University of Illinois at Chicago Health Sciences Center Chicago Illinois United States 60612
    7 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    8 Holden Comprehensive Cancer Center at The University of Iowa Iowa City Iowa United States 52242-1009
    9 Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201
    10 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    11 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    12 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
    13 Barnes-Jewish Hospital Saint Louis Missouri United States 63110
    14 University of Nebraska Medical Center Omaha Nebraska United States 68198-3330
    15 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    16 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756-0002
    17 St. Joseph's Hospital and Medical Center Paterson New Jersey United States 07503
    18 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    19 CCOP - North Shore University Hospital Manhasset New York United States 11030
    20 North Shore University Hospital Manhasset New York United States 11030
    21 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    22 New York Presbyterian Hospital - Cornell Campus New York New York United States 10021
    23 Mount Sinai Medical Center, NY New York New York United States 10029
    24 State University of New York - Upstate Medical University Syracuse New York United States 13210
    25 CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York United States 13217
    26 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    27 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    28 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    29 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
    30 Rhode Island Hospital Providence Rhode Island United States 02903
    31 Medical University of South Carolina Charleston South Carolina United States 29425-0721
    32 University of Tennessee, Memphis Cancer Center Memphis Tennessee United States 38103
    33 Vermont Cancer Center Burlington Vermont United States 05401-3498
    34 MBCCOP - Massey Cancer Center Richmond Virginia United States 23298-0037

    Sponsors and Collaborators

    • Alliance for Clinical Trials in Oncology
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Antonius A. Miller, MD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alliance for Clinical Trials in Oncology
    ClinicalTrials.gov Identifier:
    NCT00003130
    Other Study ID Numbers:
    • CALGB-9763
    • U10CA031946
    • CALGB-9763
    • CDR0000065893
    First Posted:
    Nov 25, 2003
    Last Update Posted:
    Jul 19, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by Alliance for Clinical Trials in Oncology
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasms
    Paclitaxel

    Study Results

    No Results Posted as of Jul 19, 2016