Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

Phase 2

Completed

• Conditions: Cervical Squamous Cell Carcinoma, Not Otherwise Specified; Recurrent Cervical Carcinoma
• Interventions: Drug: Docetaxel

• Registration Number: NCT00041093
• Lead Sponsor: Gynecologic Oncology Group

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.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-07-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-10-23
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (docetaxel)	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.

Primary Outcome Measures

Name	Time	Method
Frequency and duration of objective response as assessed on radiologic scan	5 years
Duration of progression-free interval	5 years
Survival time	5 years
Frequency and severity of observed adverse effects	5 years

Trial Locations

Locations (1)

Gynecologic Oncology Group; 🇺🇸 Philadelphia, Pennsylvania, United States