• Pathologic complete response [ Designated as safety issue: No ]
• Pharmacodynamics [ Designated as safety issue: No ]
• Assessment of tolerance to the regimen [ Designated as safety issue: Yes ]

• Pathologic complete response
• Pharmacodynamics
• Assessment of tolerance to the regimen

RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying the side effects of giving erlotinib together with carboplatin and paclitaxel and to see how well it works in treating patients with stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.

OBJECTIVES:

Primary

• Determine the rate of pathologic complete response (pCR) in patients with stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with paclitaxel, carboplatin, and erlotinib.
• Determine the degree and type of toxicity of this regimen in these patients.

Secondary

• Correlate pCR with epidermal growth factor receptor (EGFR), p110 truncated EGFR isoform (pEGFR), and related signal transduction pathway protein expression levels in patients treated with this regimen.
• Determine changes in EGFR and pEGFR levels and other related signal transduction pathway expression in patients treated with this regimen.
• Determine the tolerability of twelve months of maintenance therapy with erlotinib in patients achieving pCR, and measure the progression-free interval of these patients.
• Correlate the degree of skin rash with clinical and translational endpoints, through prospective documentation of cutaneous effects, in patients treated with this regimen.

OUTLINE: This is a non-randomized study. Patients are stratified according to disease stage (stage III with optimal residual disease vs stage III with suboptimal residual disease or stage IV).

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.

PROJECTED ACCRUAL: A total of 47-77 patients (28-41 for stratum I and 19-36 for stratum II) will be accrued for this study within 9-16 months.

• Fallopian Tube Cancer
• Ovarian Cancer
• Peritoneal Cavity Cancer

• Drug: carboplatin
• Drug: erlotinib hydrochloride
• Drug: paclitaxel
• Procedure: adjuvant therapy

DISEASE CHARACTERISTICS:

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

  • Stage III with optimal disease after initial surgery (no more than 1 cm residual disease)
  • Stage III with suboptimal disease after initial surgery
  • Stage IV
• Must have undergone appropriate initial surgery within the past 12 weeks OR determined to be unresectable at diagnosis

• The following subtypes are eligible:

  • Serous adenocarcinoma
  • Endometrioid adenocarcinoma
  • Mucinous adenocarcinoma
  • Undifferentiated carcinoma
  • Clear cell adenocarcinoma
  • Mixed epithelial carcinoma
  • Transitional cell carcinoma
  • Malignant Brenner tumor
  • Adenocarcinoma not otherwise specified
• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR
• Karnofsky 60-100%

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)
• AST and ALT no greater than 2.5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN OR
• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No HIV-positive patients receiving combination antiretroviral therapy
• No history of allergic reaction to compounds of similar chemical or biologic composition to erlotinib or other study agents
• No ongoing or active infection
• No other uncontrolled concurrent illness
• No sensory or motor neuropathy greater than grade 1
• No medical contraindication to study regimen
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 5 years since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Other

• No other concurrent investigational agents
• No other concurrent anticancer agents or therapies