Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

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.

Study Overview

• Status: Completed
• Conditions: Cervical Squamous Cell Carcinoma, Not Otherwise Specified; Recurrent Cervical Carcinoma
• Intervention / Treatment: Drug: Docetaxel

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Gynecologic Oncology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Docetaxel; Given IV; Other Names: Taxotere; Docecad; RP56976; Taxotere Injection Concentrate

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gynecologic Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Agustin Garcia, Gynecologic Oncology Group

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): October 23, 2006

Study Registration Dates

• First Submitted: July 8, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Neoplasms, Squamous Cell; Carcinoma; Recurrence; Carcinoma, Squamous Cell; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: GOG-0127S (Other Identifier: CTEP); U10CA027469 (U.S. NIH Grant/Contract); NCI-2012-02476 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CDR0000069442