Capecitabine in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00006812
First received: December 6, 2000
Last updated: April 10, 2013
Last verified: November 2005

December 6, 2000
April 10, 2013
March 2001
July 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006812 on ClinicalTrials.gov Archive Site
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Capecitabine in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal Cancer

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 recurrent ovarian epithelial or primary peritoneal cavity cancer.

OBJECTIVES:

  • Determine the antitumor activity of capecitabine in patients with recurrent, platinum-sensitive ovarian epithelial or primary peritoneal cavity cancer.
  • Determine the nature and degree of toxicity of this drug in this patient population.

OUTLINE: This is a multicenter study.

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

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 6-12 months.

Interventional
Phase 2
Primary Purpose: Treatment
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
Drug: capecitabine
Not Provided
Garcia AA, Blessing JA, Lenz HJ, Darcy KM, Mannel RS, Miller DS, Husseinzadeh N; Gynecologic Oncology Group. Phase II clinical trial of capecitabine in ovarian carcinoma recurrent 6-12 months after completion of primary chemotherapy, with exploratory TS, DPD, and TP correlates: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Mar;96(3):810-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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July 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically proven recurrent ovarian epithelial or primary peritoneal cavity cancer
  • Measurable disease

    • At least 1 unidimensionally measurable lesion
    • Ascites and pleural effusions are not considered measurable disease
  • Prior therapy must include 1 platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or another organoplatinum compound

    • Treatment-free interval of 6-12 months after response to platinum therapy
  • Not eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least lower limit of normal

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 neuropathy (sensory and motor) greater than grade 1
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No concurrent active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior biologic or immunologic therapy
  • No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

  • See Disease Characteristics
  • If no prior therapy with paclitaxel, a second regimen including paclitaxel allowed
  • No prior capecitabine or fluorouracil
  • No prior chemotherapy for recurrent or persistent disease, including pretreatment with initial chemotherapy regimens
  • Recovered from prior chemotherapy

Endocrine therapy:

  • At least 1 week since prior hormonal therapy directed at malignant tumor
  • Concurrent continuation of hormone replacement therapy allowed

Radiotherapy:

  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to site(s) of measurable disease
  • No prior radiotherapy to more than 25% of bone marrow

Surgery:

  • Recovered from prior surgery

Other:

  • No prior cancer treatment that would preclude study therapy
  • No concurrent amifostine or other protective reagents
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00006812
CDR0000068330, GOG-0146L
Not Provided
Not Provided
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Agustin Garcia, MD University of Southern California
Gynecologic Oncology Group
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP