Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer

OBJECTIVES:

Primary

• Compare the benefits, in terms of progression-free survival, of maintenance therapy comprising erlotinib vs observation in patients with responding or stable disease after first-line, platinum-based chemotherapy for high-risk stage I or stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Secondary

• Compare the overall survival of patients treated with these regimens.
• Determine the safety of erlotinib in these patients.
• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (I-II vs III-IV), participating center, age (≤ 65 vs > 65), response to first-line therapy (no evidence of disease/complete response vs partial response vs stable disease), and first-line therapy (platinum-based vs platinum/taxane combination vs platinum-based triplet). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral erlotinib once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients undergo observation as per standard of care. Quality of life is assessed at baseline and then every 3 months for up to 2 years.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 830 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer meeting 1 of the following criteria:

• High-risk stage I disease, as defined by grade 3, aneuploid grade 1 or 2, or clear cell disease
• Stage II, III, or IV disease
• Completed first-line therapy within the past 6 weeks

• Received a platinum derivative (carboplatin or cisplatin) alone or in combination with other agents for 6-9 courses
• Must have achieved complete response/no evidence of disease, partial response, or stabilization of disease after therapy
• No adenocarcinoma of unknown origin
• No known brain metastases or leptomeningeal disease

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Platelet count ≥ 100,000/mm^3
• WBC ≥ 2,000/mm^3

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with known liver metastases)
• Bilirubin ≤ 1.5 times ULN
• Alkaline phosphatase ≤ 5 times ULN except in patients with known bone metastases
• PT and PTT ≤ 1.5 times ULN

Renal

• Creatinine ≤ 2 times ULN

Cardiovascular

• No myocardial infarction within past 6 months
• No second- or third-degree heart block without pacemaker

Gastrointestinal

• No active peptic ulcer disease
• No gastrointestinal tract disease that would interfere with ability to take oral medications, affect absorption, or require parenteral nutrition
• No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No significant dermatologic disease
• No inflammatory changes to the surface of the eye
• No history of allergic reaction to compounds of similar chemical composition as erlotinib
• No other significant medical condition or neurologic or psychiatric disorder
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or cone-biopsied carcinoma in situ of the cervix
• No psychiatric illness or familial, geographic, or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior therapy targeting epidermal growth factor receptor
• No concurrent immunotherapy

Chemotherapy

• See Disease Characteristics
• See Surgery
• No concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy

Radiotherapy

• No prior radiotherapy unless completed more than 5 years ago AND outside the abdomen/pelvis

Surgery

• Interval debulking surgery after 3 courses of chemotherapy and second-look surgery at the end of chemotherapy allowed as per study EORTC-55971/NCIC OV13/Chorus

Other

• No other prior or concurrent investigational agents
• No other concurrent anticancer treatment
• Concurrent participation in study EORTC-55971/NCIC-OV13/Chorus allowed