- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00039442
Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer
A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85012
- Gynecologic Oncology Group of Arizona
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Patients receive oral capecitabine twice daily on days 1-14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of objective response
Time Frame: Up to 7 years
|
Up to 7 years
|
Frequency of adverse events, graded according to CTC version 2.0
Time Frame: Up to 7 years
|
Up to 7 years
|
Frequency of objective response
Time Frame: Up to 7 years
|
Up to 7 years
|
Severity of observed adverse events, graded according CTC version 2.0
Time Frame: Up to 7 years
|
Up to 7 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine Look, Gynecologic Oncology Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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, Complex and Mixed
- Carcinoma
- Recurrence
- Carcinoma, Adenosquamous
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
Other Study ID Numbers
- GOG-0128G (Other Identifier: CTEP)
- U10CA027469 (U.S. NIH Grant/Contract)
- NCI-2012-02469 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000069384
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Adenocarcinoma
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Catalysis SLCompletedCervical Carcinoma Stage II | Cervical Carcinoma Stage III | Cervical Carcinoma Stage IV | Endometrial Adenocarcinoma Stage II | Endometrial Adenocarcinoma Stage III | Endometrial Adenocarcinoma Stage IVCuba
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Merck Sharp & Dohme LLCCompletedPrevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in SituChina
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Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
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Tampere University HospitalKarolinska Institutet; Tampere University; European UnionEnrolling by invitationCervical Intraepithelial Neoplasia Grade 2/3 | Adenocarcinoma in SituFinland
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Shanghai Gynecologic Oncology GroupFudan UniversityCompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Malignant Neoplasm of Cervix Stage IB1 | Stage IIA1 Cervical CancerChina
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Merck Sharp & Dohme LLCCompletedCervical Cancer | Cervical Intraepithelial Neoplasia | Adenocarcinoma in Situ
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National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
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