Docetaxel and Carboplatin in Treating Patients With Recurrent Stage IVB Squamous Cell Carcinoma (Cancer) of the Cervix

August 8, 2018 updated by: Wake Forest University Health Sciences

Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining docetaxel with carboplatin may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with carboplatin and to see how well they work in treating patients with recurrent stage IVB squamous cell carcinoma (cancer) of the cervix.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of docetaxel when administered with carboplatin in patients with recurrent stage IVB squamous cell carcinoma of the cervix.
  • Determine the response rate and time to progression in patients treated with this regimen.

Secondary

  • Determine the toxicity of this regimen in these patients.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE: This is phase I, dose-escalation study of docetaxel followed by a phase II study.

  • Phase I: Patients receive docetaxel IV over 30 minutes and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients who demonstrate continuing tumor shrinkage after 6 courses receive 2 additional courses beyond their best response.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive docetaxel and carboplatin as in phase I at the MTD determined in phase I.

Quality of life is assessed at baseline, before every other course of treatment, and at the end of study treatment.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for phase I and 16-40 for phase II) will be accrued for this study within 2 years.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

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
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1065
        • Wake Forest University Comprehensive 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 to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the uterine cervix

    • Advanced disease (stage IVB)
    • Persistent or recurrent disease
  • No available curative treatment options
  • Measurable disease by physical examination, chest x-ray, CT scan, or MRI

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • GOG 0-2

Life expectancy

  • More than 6 months

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 8 g/dL

Hepatic

  • Bilirubin normal
  • SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR
  • Alkaline phosphatase ≤ 4 times ULN AND SGOT and SGPT normal

Renal

  • Creatinine < 1.5 times ULN

Other

  • No other invasive malignancy within the past 5 years
  • No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No peripheral neuropathy > grade 1
  • No other concurrent malignancy except curatively treated non-melanoma skin cancer
  • No other serious medical or psychiatric illness that would preclude giving informed consent or limit survival
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent biologic therapy

Chemotherapy

  • No more than 2 prior chemotherapy regimens

    • One sensitizing chemotherapy regimen during radiotherapy AND 1 regimen for recurrent disease are considered 2 regimens
  • At least 4 weeks since prior chemotherapy
  • No prior docetaxel
  • No prior carboplatin
  • No other concurrent chemotherapy

Endocrine therapy

  • At least 4 weeks since prior hormonal therapy

Radiotherapy

  • See Chemotherapy
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • At least 3 weeks since prior 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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose of docetaxel
Time Frame: 28 days
28 days

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

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

Study Start

November 1, 2003

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

June 10, 2004

First Submitted That Met QC Criteria

June 10, 2004

First Posted (ESTIMATE)

June 11, 2004

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000366942
  • CCCWFU-30102B
  • NCI-6949

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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