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Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Squamous Cell Carcinoma, Not Otherwise Specified

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (docetaxel)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 8, 2002
Last Updated
January 9, 2018
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00041093
Brief Title
Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer
Official Title
A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
October 23, 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Recurrent Cervical Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (docetaxel)
Arm Type
Experimental
Arm Description
Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Duration of progression-free interval
Time Frame
5 years
Title
Frequency and duration of objective response as assessed on radiologic scan
Time Frame
5 years
Title
Frequency and severity of observed adverse effects
Time Frame
5 years
Title
Survival time
Time Frame
5 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agustin Garcia
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

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