Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

Gynecologic Oncology Group (GOG)

Status and phase

Completed

Phase 2

Conditions

Cervical Squamous Cell Carcinoma, Not Otherwise Specified

Recurrent Cervical Carcinoma

Treatments

Drug: Docetaxel

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00041093

U10CA027469 (U.S. NIH Grant/Contract)

CDR0000069442

GOG-0127S (Other Identifier)

NCI-2012-02476 (Registry Identifier)

Details and patient eligibility

About

Phase II trial to study the effectiveness of docetaxel in treating patients who have persistent or recurrent cervical cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Full description

PRIMARY OBJECTIVES:

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

II. 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.

Enrollment

27 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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
- 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)
Performance status - GOG 0-2
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
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
Recovered from prior chemotherapy
No prior docetaxel
No more than 1 prior cytotoxic chemotherapy regimen
At least one week since prior hormonal therapy directed at malignant tumor
Concurrent hormone replacement therapy allowed
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