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Status:

COMPLETED

Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Cervical Cancer

Eligibility:

FEMALE

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well topot...

Detailed Description

OBJECTIVES: * Determine the antitumor activity of topotecan in patients with persistent or recurrent carcinoma of the cervix that failed higher priority treatment protocols. * Determine the nature an...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed carcinoma of the cervix
  • Squamous cell or nonsquamous cell
  • Persistent or recurrent disease
  • Documented disease progression
  • Measurable disease
  • At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Tumors within a previously irradiated field are considered non-target lesions unless disease progression is documented or a biopsy is obtained to confirm persistent disease at least 90 days after completion of prior radiotherapy
  • Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or nonsquamous cell carcinoma of the cervix
  • Chemotherapy administered with primary radiotherapy as a radiosensitizer is not considered a systemic chemotherapy regimen
  • Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • GOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Other
  • Sensory or motor neuropathy ≤ grade 1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following:
  • Monoclonal antibodies
  • Cytokines
  • Small-molecule inhibitors of signal transduction
  • At least 3 weeks since prior biologic or immunologic agents for cervical cancer
  • No concurrent prophylactic growth factors, including filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim
  • No concurrent prophylactic thrombopoietic agents
  • Chemotherapy
  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
  • No prior topotecan
  • Endocrine therapy
  • At least 1 week since prior hormonal therapy for cervical cancer
  • Concurrent hormone replacement therapy allowed
  • Radiotherapy
  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • Surgery
  • Recovered from prior surgery
  • Other
  • At least 3 weeks since other prior therapy for cervical cancer
  • No prior cancer therapy that would preclude study participation

Exclusion

    Key Trial Info

    Start Date :

    February 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    27 Patients enrolled

    Trial Details

    Trial ID

    NCT00087126

    Start Date

    February 1 2005

    Last Update

    January 8 2019

    Active Locations (27)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 7 (27 locations)

    1

    Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Kaiser Permanente Medical Center - Los Angeles

    Los Angeles, California, United States, 90027

    3

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095-1781

    4

    Olive View - UCLA Medical Center Foundation

    Sylmar, California, United States, 91342