Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer

December 17, 2018 updated by: Gynecologic Oncology Group

A Phase II Evaluation of Weekly Topotecan Hydrochloride (Hycamtin®, NSC #609699) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix

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 topotecan works in treating women with persistent or recurrent cervical cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patient are followed for every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-2 years.

Study Type

Interventional

Enrollment (Actual)

27

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
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Medical Center - Los Angeles
      • Sylmar, California, United States, 91342
        • Olive View - UCLA Medical Center Foundation
    • Connecticut
      • Hartford, Connecticut, United States, 06102-5037
        • Helen and Harry Gray Cancer Center at Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
      • New Haven, Connecticut, United States, 06520-8028
        • Yale Cancer Center
    • Florida
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
    • Georgia
      • Savannah, Georgia, United States, 31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Cancer Clinic
      • Pascagoula, Mississippi, United States, 39581
        • Regional Cancer Center at Singing River Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Estabrook Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Columbus, Ohio, United States, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
      • Dayton, Ohio, United States, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Cancer Institute
      • Tulsa, Oklahoma, United States, 74104
        • Cancer Care Associates - Midtown Tulsa
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital of Rhode Island

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 to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topotecan
Topotecan weekly
Drug: topotecan hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Time Frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Time Frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
All participants assessed by CTCAE v3 (Common Terminology Criteria for Adverse Events version 3.0) including grade 0 (the number of participants not affected by the Adverse Event).
Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

Collaborators and Investigators

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

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: James V. Fiorica, MD, Sarasota Memorial Hospital

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

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

February 1, 2005

Primary Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

July 8, 2004

First Submitted That Met QC Criteria

July 9, 2004

First Posted (Estimate)

July 12, 2004

Study Record Updates

Last Update Posted (Actual)

January 8, 2019

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0127U
  • CDR0000372930 (Other Identifier: CDR)

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.

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