Recurrent Cervical Carcinoma Clinical Trial
Official title:
A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
Verified date | January 2018 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | |
Est. primary completion date | October 23, 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Gynecologic Oncology Group | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of progression-free interval | 5 years | ||
Primary | Frequency and duration of objective response as assessed on radiologic scan | 5 years | ||
Primary | Frequency and severity of observed adverse effects | 5 years | ||
Primary | Survival time | 5 years |
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