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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00084890
Recruitment Status : Terminated (slow accrual)
First Posted : June 11, 2004
Last Update Posted : August 10, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: carboplatin Drug: docetaxel Phase 1

Detailed Description:



  • 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.


  • 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  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study
Study Start Date : November 2003
Actual Primary Completion Date : March 2007
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: carboplatin
    30 minute infusion dosed based on glomerular filtration rate of patient
  • Drug: docetaxel
    escalating doses ofstarting at 25 milligrams per meter squared

Primary Outcome Measures :
  1. Maximum tolerated dose of docetaxel [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status

  • GOG 0-2

Life expectancy

  • More than 6 months


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


  • 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


  • Creatinine < 1.5 times ULN


  • 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


Biologic therapy

  • No concurrent biologic therapy


  • 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


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


  • At least 3 weeks since prior major surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00084890

United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1065
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: Brigitte E. Miller, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences Identifier: NCT00084890     History of Changes
Other Study ID Numbers: CDR0000366942
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
stage IVB cervical cancer
recurrent cervical cancer
cervical squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action