Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Not specified	NCI	GOG-0127S NCT00041093

Objectives

1. Determine the antitumor activity of docetaxel in patients with persistent or recurrent squamous cell carcinoma of the cervix.
2. Determine the toxicity of this drug in these patients.

Entry 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)

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

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

Expected Enrollment

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

Outcomes

Response rate by GOG RECIST criteria every 8 weeks

Frequency and severity of adverse events by NCI CTC v2.0 every 4 weeks
Overall survival
Duration of progression-free interval

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.

Garcia AA, Blessing JA, Vaccarello L, et al.: Phase II clinical trial of docetaxel in refractory squamous cell carcinoma of the cervix: a Gynecologic Oncology Group Study. Am J Clin Oncol 30 (4): 428-31, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Agustin Garcia, MD, Protocol chair(Contact information may not be current)		Ph: 310-600-8400 Email: agarcia@premiereoncology.com

Registry Information
Official Title		A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
Trial Start Date		2002-06-03
Trial Completion Date		2008-01-26
Registered in ClinicalTrials.gov		NCT00041093
Date Submitted to PDQ		2002-05-22
Information Last Verified		2005-08-23
NCI Grant/Contract Number		CA27469

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