• 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 ]
  

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.

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