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

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.

OBJECTIVES:

* Determine the antitumor cytostatic activity of gefitinib, in terms of 6-month progression-free survival, in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma.
* Determine the nature and degree of toxicity in patients treated with this drug.
* Determine the partial and complete response rates in patients treated with this drug.
* Determine the duration of progression-free and overall survival in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib once daily. Courses repeat every 28 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: Approximately 22-60 patients will be accrued for this study within 1-2 years.

Eligibility 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