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

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Primary Peritoneal Cavity Cancer; Ovarian Cancer

Treatments: Drug: gefitinib

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00023699

GOG-0170C

CDR0000068852

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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