Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

NCT ID: NCT00041093

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30

Brief Summary

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.

Detailed 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.

Conditions

Cervical Squamous Cell Carcinoma, Not Otherwise Specified; Recurrent Cervical Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (docetaxel)

Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Given IV

Interventions

Docetaxel

Given IV

Intervention Type: DRUG

Other Intervention Names

Docecad; RP56976; Taxotere; Taxotere Injection Concentrate

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agustin Garcia

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02476

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000069442

Identifier Type: -

Identifier Source: secondary_id

GOG-0127S

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0127S

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0127S

Identifier Type: -

Identifier Source: org_study_id