Gefitinib in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gefitinib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial or primary peritoneal carcinoma

• Recurrent or persistent disease

• Must have had prior therapy with no more than 1 platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease

• Platinum-resistant or refractory

• Treatment-free interval of less than 6 months after therapy with platinum-containing regimen OR

• Progression during platinum-containing regimen OR

• Platinum sensitive defined as treatment-free interval without disease progression for more than 6 months but less than 12 months after therapy with platinum-containing regimen

• At least 1 lesion measurable in at least 1 dimension

• At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR

• At least 10 mm by spiral CT scan

• At least 1 target lesion outside a previously irradiated field

• Disease must be accessible to core needle biopsy

• Ineligible for higher priority GOG protocol

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 no greater than 1.5 times ULN

Cardiovascular:

• No unstable cardiac disease

• No myocardial infarction within the past 6 months

• Coronary artery disease, congestive heart failure, and dysrhythmia allowed if on stable regimen for at least 3 months

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• No sensory or motor neuropathy greater than grade 1

• No active corneal disease (e.g., keratoconjunctivitis)

• No active infection requiring antibiotics

• No evidence of bowel dysfunction that could be related to early bowel obstruction

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior immunological agents for the malignancy

• No concurrent anti-cancer immunotherapy

Chemotherapy:

• See Disease Characteristics

• No more than 1 additional prior cytotoxic chemotherapy regimen for recurrent or persistent disease

• No prior noncytotoxic chemotherapy for recurrent or persistent disease

• At least 3 weeks since prior chemotherapy for the malignancy and recovered

• No concurrent anti-cancer chemotherapy

Endocrine therapy:

• At least 1 week since prior anticancer hormonal therapy

• Concurrent hormone replacement therapy allowed

• No concurrent anti-cancer hormonal therapy

Radiotherapy:

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy for the malignancy and recovered

• No prior radiotherapy to more than 25% of marrow-bearing areas

• No concurrent anti-cancer radiotherapy

Surgery:

• At least 4 weeks since prior surgery (except minor procedures under local anesthesia (e.g., central venous port placement)) and recovered

Other:

• At least 3 weeks since other prior therapy for the malignancy

• No prior gefitinib

• No other prior epidermal growth factor receptor inhibitors

• No prior anticancer therapy that would preclude study therapy

• No concurrent chlorpromazine

• No other concurrent investigational agents

• No other concurrent antineoplastic agents

• No concurrent CYP3A4-inducing agents, including phenytoin, carbamazepine, barbiturates, nafcillin, rifampicin, or St. John's Wort