Paclitaxel, Topotecan, and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

May 24, 2013 updated by: Gynecologic Oncology Group

A Limited Access Phase II Trial of Weekly Topotecan (NSC #609699), Paclitaxel (NSC #673089), and Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with topotecan and cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Estimate the antitumor activity of the combination of paclitaxel, topotecan, and cisplatin in patients with advanced, persistent, or recurrent carcinoma of the cervix.
  • Determine the nature and degree of toxicity for this drug regimen in these patients.

Secondary

  • Determine the duration of progression-free survival and overall survival.
  • Determine the impact of prior chemoradiation on response to treatment.

OUTLINE: This is an open-label study.

Patients receive paclitaxel IV over 1 hour followed by topotecan IV over 30 minutes and cisplatin IV over 1 hour on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 2

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

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Advanced, persistent, or recurrent squamous or nonsquamous cell carcinoma of the cervix with documented disease progression

    • Histologic confirmation of the original primary tumor is required

  • Disease must be measurable in at least one dimension by conventional techniques, including palpation, plain x-ray, CT scan, or MRI

    • Measurable disease is defined as at least one lesion that can be accurately measured
    • Each lesion must be ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
    • Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiation therapy

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • SGOT and alkaline phosphatase ≤ 2.5 times ULN
  • Neuropathy (sensory and motor) ≤ grade 1
  • No active infection requiring antibiotics

  • No evidence of more than one malignancy present within the past 5 years

    • Nonmelanoma skin cancer allowed
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No prior therapy with cytotoxic drugs for advanced or recurrent cervical carcinoma

    • Prior cisplatin as a radiosensitizer for primary treatment of disease allowed
  • No previous cancer treatment that contraindicates study treatment
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of cervical cancer
  • No prior chemotherapy for any abdominal or pelvic tumor except for the treatment of cervical cancer
  • Recovered from effects of recent surgery, radiotherapy, or other therapy
  • At least 4 weeks since prior radiotherapy
  • More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and free of recurrent or metastatic disease
  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer provided patient is free of recurrent or metastatic disease
  • No hormonal therapy directed at the malignant tumor within the past week
  • Concurrent hormone replacement therapy is permitted
  • No concurrent amifostine or other protective reagents

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The frequency and duration of objective response
The frequency and severity of observed adverse effects

Secondary Outcome Measures

Outcome Measure
Progression-free survival and overall survival
Prognostic factor: prior chemoradiation

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)

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

Primary Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (ESTIMATE)

January 13, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 27, 2013

Last Update Submitted That Met QC Criteria

May 24, 2013

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000456248
  • GOG-0076EE

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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