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A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

Phase 2
Not Enrolling
Cervical Cancer

Thank you

Trial Information

A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix


- Determine the antitumor activity of docetaxel in patients with persistent or recurrent
squamous cell carcinoma of the cervix.

- Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within at least
6-7 months.

Inclusion Criteria


- Histologically confirmed persistent or recurrent squamous cell carcinoma of the

- Progressive disease

- At least 1 unidimensionally measurable target lesion

- At least 20 mm by conventional techniques OR

- At least 10 mm by spiral CT scan

- Tumors within a previously irradiated field are not considered target lesions

- One prior systemic chemotherapeutic regimen for advanced, metastatic, or recurrent
squamous cell carcinoma of the cervix required

- Chemotherapy administered as a radiosensitizer in conjunction with primary
radiotherapy is not considered a systemic chemotherapy regimen

- Ineligible for a higher priority GOG protocol (e.g., any active Phase III GOG
protocol or GOG-0076)



- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN


- Creatinine no greater than 1.5 times ULN


- No congestive heart failure

- No unstable angina, myocardial infarction, or new cardiac arrhythmia within the past
6 months


- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection requiring antibiotics

- No greater than grade 1 sensory and motor neuropathy

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer


Biologic therapy:

- At least 3 weeks since prior biologic or immunologic therapy directed at malignant

- One prior noncytotoxic regimen (e.g., monoclonal antibodies, cytokines, or
small-molecule signal transduction inhibitors) for recurrent or persistent disease


- See Disease Characteristics

- Recovered from prior chemotherapy

- No prior docetaxel

- No more than 1 prior cytotoxic chemotherapy regimen

Endocrine therapy:

- At least one week since prior hormonal therapy directed at malignant tumor

- Concurrent hormone replacement therapy allowed


- See Disease Characteristics

- Recovered from prior radiotherapy


- Recovered from recent prior surgery


- At least 3 weeks since any prior therapy directed at malignant tumor

- No prior anticancer therapy that would preclude study

- No concurrent amifostine or other protective agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response rate by GOG RECIST criteria every 8 weeks

Safety Issue:


Principal Investigator

Agustin Garcia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cedars-Sinai Medical Center


United States: Federal Government

Study ID:




Start Date:

June 2002

Completion Date:

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • cervical squamous cell carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms



University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Duke Comprehensive Cancer Center Durham, North Carolina  27710
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
University of Texas Medical Branch Galveston, Texas  77555-1329
CCOP - Western Regional, Arizona Phoenix, Arizona  85006-2726
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
CCOP - Evanston Evanston, Illinois  60201
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Keesler Medical Center - Keesler Air Force Base Keesler AFB, Mississippi  39534-2576
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
UPMC Cancer Center at Magee-Womens Hospital Pittsburgh, Pennsylvania  15213-3180
Southeast Gynecologic Oncology Associates Knoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
CCOP - Scott and White Hospital Temple, Texas  76508
Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham, Alabama  35294
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles, California  90048-1865
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
University of Virginia Cancer Center Charlottesville, Virginia  22908