Paclitaxel in Treating Women With Recurrent Solid Tumors

July 15, 2016 updated by: Alliance for Clinical Trials in Oncology

Prospective Evaluation of Body Surface Area (BSA) as a Determinant of Paclitaxel Pharmacokinetics/Pharmacodynamics in Women With Solid Tumors

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.

Study Overview

Status

Completed

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment

Drug: paclitaxel

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 Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / 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

Participant Group / 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Miller AA, Rosner GL, Egorin MJ, Hollis D, Lichtman SM, Ratain MJ. Prospective evaluation of body surface area as a determinant of paclitaxel pharmacokinetics and pharmacodynamics in women with solid tumors: Cancer and Leukemia Group B Study 9763. Clin Cancer Res. 2004 Dec 15;10(24):8325-31. doi: 10.1158/1078-0432.CCR-04-1078.
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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1997

Primary Completion (Actual)

January 1, 2002

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

November 24, 2003

First Posted (Estimate)

November 25, 2003

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

unspecified adult solid tumor, protocol specific

Additional Relevant MeSH Terms

Other Study ID Numbers

CALGB-9763
U10CA031946 (U.S. NIH Grant/Contract)
CDR0000065893 (Registry Identifier: NCI Physician Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.