Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have persistent or recurrent cervical cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix |
- Response rate by GOG RECIST criteria every 8 weeks [ Designated as safety issue: No ]
- Frequency and severity of adverse events by NCI CTC v2.0 every 4 weeks [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- Duration of progression-free interval [ Designated as safety issue: No ]
| Study Start Date: | June 2002 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 36 Study Locations| Study Chair: | Agustin Garcia, MD | Cedars-Sinai Medical Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00041093 History of Changes |
| Other Study ID Numbers: | CDR0000069442, GOG-0127S |
| Study First Received: | July 8, 2002 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent cervical cancer cervical squamous cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Uterine Cervical Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female |
Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013