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

Study Overview
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Brief Summary
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RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sometimes after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether erlotinib is more effective than observation after first-line chemotherapy in treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer. PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to observation in treating patients who have undergone first-line chemotherapy for ovarian cancer, peritoneal cancer, or fallopian tube cancer.

Detailed Description
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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.

Official Title
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A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: erlotinib hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

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
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: erlotinib hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Adverse event profile |  |  | 
| Quality of life |  |  | 
| Cutaneous toxicity (rash or acne [papulo-pustular rash]) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer