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Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer

Primary Purpose

Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Recurrent Cervical Carcinoma

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

About this trial

This is an interventional treatment trial for Cervical Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria: Histologically confirmed primary non-squamous cell carcinoma (non-SCC) of the cervix Persistent or recurrent disease Eligible subtypes include: Adenocarcinoma Adenosquamous cell carcinoma Undifferentiated carcinoma Documented disease progression At least 1 unidimensionally measurable target lesion outside prior irradiation field At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, and MRI) At least 10 mm by spiral CT scan Received 1 prior systemic chemotherapy regimen for advanced, metastatic, or recurrent non-SCC of the cervix Radiosensitizing chemotherapy administered in combination with primary radiotherapy is not counted as a systemic chemotherapy regimen Tissue blocks from initial diagnosis, metastasis, or recurrence available for submission to the GOG tissue bank Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol (if one exists), defined as any Temporarily closed GOG phase III protocol for the same patient population Performance status - GOG 0-2 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 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 clearance at least 50 mL/min Not pregnant Negative pregnancy test Fertile patients must use effective contraception No Temporarily closed infection requiring antibiotics No grade 2 or greater sensory or motor neuropathy No other invasive malignancy within the past 5 years except nonmelanoma skin cancer At least 3 weeks since prior biological or immunological anticancer agents No more than 1 prior non-cytotoxic biologic therapy or cytostatic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) for recurrent or persistent non-SCC of the cervix See Disease Characteristics See Biologic therapy At least 3 weeks since prior chemotherapy and recovered No prior capecitabine No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy) At least 1 week since prior hormonal anticancer therapy Concurrent hormone replacement therapy allowed See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Recovered from prior recent surgery At least 3 weeks since other prior anticancer therapy No prior cancer treatment that would preclude this study therapy

Sites / Locations

  • Gynecologic Oncology Group of Arizona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Duration of objective response
Frequency of adverse events, graded according to CTC version 2.0
Frequency of objective response
Severity of observed adverse events, graded according CTC version 2.0

Secondary Outcome Measures

Full Information

First Posted
June 6, 2002
Last Updated
August 23, 2017
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00039442
Brief Title
Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer
Official Title
A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 29, 2002 (Actual)
Primary Completion Date
December 7, 2005 (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 capecitabine 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 capecitabine in patients with persistent or recurrent non-squamous cell carcinoma of the cervix who have failed higher priority treatment protocols. II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine whether the mRNA tumor expression levels of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), and thymidine phosphorylase (TP) at baseline are potential predictors of clinical outcomes (response and survival) in patients treated with this drug. IV. Determine whether the serum level of TP is a potential prognostic indicator of clinical outcomes (response and survival) in patients treated with this drug. V. Determine whether the TS promoter polymorphism in peripheral blood is a potential prognostic indicator of clinical outcomes (response and survival) in patients treated with this drug. VI. Determine the associations among the various measures of TS, DPD, and TP and clinical outcomes (response and survival) in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 1-14. 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 Adenocarcinoma, Cervical Adenosquamous Carcinoma, 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
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Duration of objective response
Time Frame
Up to 7 years
Title
Frequency of adverse events, graded according to CTC version 2.0
Time Frame
Up to 7 years
Title
Frequency of objective response
Time Frame
Up to 7 years
Title
Severity of observed adverse events, graded according CTC version 2.0
Time Frame
Up to 7 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed primary non-squamous cell carcinoma (non-SCC) of the cervix Persistent or recurrent disease Eligible subtypes include: Adenocarcinoma Adenosquamous cell carcinoma Undifferentiated carcinoma Documented disease progression At least 1 unidimensionally measurable target lesion outside prior irradiation field At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, and MRI) At least 10 mm by spiral CT scan Received 1 prior systemic chemotherapy regimen for advanced, metastatic, or recurrent non-SCC of the cervix Radiosensitizing chemotherapy administered in combination with primary radiotherapy is not counted as a systemic chemotherapy regimen Tissue blocks from initial diagnosis, metastasis, or recurrence available for submission to the GOG tissue bank Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol (if one exists), defined as any Temporarily closed GOG phase III protocol for the same patient population Performance status - GOG 0-2 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 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 clearance at least 50 mL/min Not pregnant Negative pregnancy test Fertile patients must use effective contraception No Temporarily closed infection requiring antibiotics No grade 2 or greater sensory or motor neuropathy No other invasive malignancy within the past 5 years except nonmelanoma skin cancer At least 3 weeks since prior biological or immunological anticancer agents No more than 1 prior non-cytotoxic biologic therapy or cytostatic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) for recurrent or persistent non-SCC of the cervix See Disease Characteristics See Biologic therapy At least 3 weeks since prior chemotherapy and recovered No prior capecitabine No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy) At least 1 week since prior hormonal anticancer therapy Concurrent hormone replacement therapy allowed See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Recovered from prior recent surgery At least 3 weeks since other prior anticancer therapy No prior cancer treatment that would preclude this study therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Look
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer

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