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Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003054
First received: November 1, 1999
Last updated: April 10, 2013
Last verified: May 2003
  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 patients with recurrent or persistent cancer of the uterus.


Condition Intervention Phase
Sarcoma
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Evaluation of Paclitaxel (Taxol) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Study Start Date: August 1997
Estimated Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Estimate the antitumor activity of paclitaxel in patients with metastatic or persistent leiomyosarcoma of the uterus who have failed treatment protocols of higher priority. II. Determine the nature and degree of toxic effects of paclitaxel in this group of patients.

OUTLINE: Patients receive a continuous infusion of paclitaxel once every 3 weeks over 3 hours. Patients in complete remission, partial remission, or stable disease undergo at least 3 courses of paclitaxel. Paclitaxel continues until disease progression or adverse effects prohibit further treatment. All patients are followed until death.

PROJECTED ACCRUAL: This study anticipates an annual accrual of approximately 25 patients over 2.5 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or established treatments Measurable disease required Must have failed local therapeutic measures and must be considered incurable Not eligible for GOG protocols of higher priority

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT and alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No unstable angina within 6 months OR No myocardial infarction within 6 months Abnormal cardiac condition (e.g., bundle branch block, heart block) allowed if stable for 6 months Other: No significant infection No concomitant malignancy other than nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: At least 3 weeks since prior therapy to malignant tumor Biologic therapy: Not specified Chemotherapy: Recovery from prior chemotherapy required No more than 1 prior chemotherapy regimen allowed No prior paclitaxel No prior chemotherapy for any malignancy from which the patient is disease-free for at least 5 years Endocrine therapy: Not specified Radiotherapy: Recovery from prior radiation therapy required No prior radiation therapy for any malignancy from which the patient is disease-free for at least 5 years Surgery: Recovery from prior surgery required

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003054

  Show 65 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Donald G. Gallup, MD Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00003054     History of Changes
Other Study ID Numbers: CDR0000065702, GOG-131C
Study First Received: November 1, 1999
Last Updated: April 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
recurrent uterine sarcoma
uterine leiomyosarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014