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Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer
This study has been completed.
First Received: June 6, 2002   Last Updated: February 13, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039442
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have persistent or recurrent cervical cancer.


Condition Intervention Phase
Cervical Cancer
Drug: capecitabine
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2002
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.
  • Determine the nature and degree of toxicity of this drug in these patients.
  • 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.
  • Determine whether the serum level of TP is a potential prognostic indicator of clinical outcomes (response and survival) in patients treated with this drug.
  • 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.
  • 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.

PROJECTED ACCRUAL: A total of 15-37 patients will be accrued for this study within approximately 5-12 months.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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) OR
    • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • 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

Renal:

  • Creatinine clearance at least 50 mL/min

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • 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

Chemotherapy:

  • 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)

Endocrine therapy:

  • At least 1 week since prior hormonal anticancer therapy
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered

Surgery:

  • Recovered from prior recent surgery

Other:

  • At least 3 weeks since other prior anticancer therapy
  • No prior cancer treatment that would preclude this study therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039442

  Show 48 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Katherine Y. Look, MD Indiana University Melvin and Bren Simon Cancer Center
Investigator: Agustin Garcia, MD Cedars-Sinai Medical Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069384, GOG-0128G
Study First Received: June 6, 2002
Last Updated: February 13, 2009
ClinicalTrials.gov Identifier: NCT00039442     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent cervical cancer
cervical adenocarcinoma
cervical adenosquamous cell carcinoma

Additional relevant MeSH terms:
Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009