Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Not specified	NCI	GOG-0128G NCT00039442

Objectives

1. 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.
2. Determine the nature and degree of toxicity of this drug in these patients.
3. 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.
4. Determine whether the serum level of TP is a potential prognostic indicator of clinical outcomes (response and survival) in patients treated with this drug.
5. 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.
6. Determine the associations among the various measures of TS, DPD, and TP and clinical outcomes (response and survival) in patients treated with this drug.

Entry 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

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

Patient Characteristics:

Age:

• Not specified

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

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.

Look KY, Blessing JA, Michener CM, et al.: Phase II evaluation of capecitabine in refractory nonsquamous cell carcinoma of the cervix: a Gynecologic Oncology Group study. Int J Gynecol Cancer 18 (4): 773-8, 2008 Jul-Aug.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Katherine Look, MD, Protocol chair		Ph: 317-274-8987; 888-600-4822 Email: klook7711@sbcglobal.net
Agustin Garcia, MD, Protocol co-chair(Contact information may not be current)		Ph: 310-600-8400 Email: agarcia@premiereoncology.com

Registry Information
Official Title		A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix
Trial Start Date		2002-06-25
Trial Completion Date		2009-01-25
Registered in ClinicalTrials.gov		NCT00039442
Date Submitted to PDQ		2002-04-23
Information Last Verified		2005-07-01
NCI Grant/Contract Number		U10-CA27469

Back to Top