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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Trial of ZD1839 (Iressa) (NSC# 715055) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Conditions
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Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: gefitinib


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gefitinib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, primary peritoneal cavity cancer