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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
N/A
N/A
Not Enrolling
Female
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


OBJECTIVES:

- 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


DISEASE CHARACTERISTICS:

- Histologically confirmed persistent or recurrent squamous cell carcinoma of the
cervix

- 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)

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

Hepatic:

- 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

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No congestive heart failure

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

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

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

Chemotherapy:

- 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

Radiotherapy:

- See Disease Characteristics

- Recovered from prior radiotherapy

Surgery:

- Recovered from recent prior surgery

Other:

- 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:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response rate by GOG RECIST criteria every 8 weeks

Safety Issue:

No

Principal Investigator

Agustin Garcia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cedars-Sinai Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000069442

NCT ID:

NCT00041093

Start Date:

June 2002

Completion Date:

Related Keywords:

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

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - EvanstonEvanston, Illinois  60201
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Southeast Gynecologic Oncology AssociatesKnoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
University of Virginia Cancer CenterCharlottesville, Virginia  22908