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

Gynecologic Oncology Group (GOG)

Status and phase: Terminated; Phase 2

Conditions: Primary Peritoneal Cavity Cancer; Ovarian Cancer

Treatments: Drug: capecitabine

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00006812

CDR0000068330

GOG-0146L

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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