Erlotinib in Treating Patients With Persistent or Recurrent Cancer of the Cervix

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma (SCC) of the cervix

  • Persistent or recurrent progressive disease

  • At least 1 prior systemic chemotherapy regimen for management of advanced, metastatic, or recurrent SCC of the cervix is required

    • Chemotherapy administered as a radiosensitizer in conjunction with radiotherapy does not count as a systemic chemotherapy regimen

• At least 1 unidimensionally measurable target lesion

  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Lesions within a previously irradiated field are considered nontarget lesions unless disease progression or persistence is confirmed ≥ 90 days after completion of radiotherapy
• Tumor accessible for repeat needle biopsy
• Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (any active GOG phase III protocol for the same patient population)
• Performance status - GOG 0-2 (for patients who have received only 1 prior regimen)
• Performance status - GOG 0-1 (for patients who have received 2 prior regimens)
• Platelet count at least 100,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Bilirubin no greater than upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN
• Creatinine no greater than 1.5 times ULN
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No abnormalities of the cornea (e.g., dry eye syndrome or Sjogren's syndrome)
• No congenital abnormalities (e.g., Fuch's dystrophy)
• No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
• No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No uncontrolled concurrent illness
• No ongoing or active infection requiring IV antibiotics
• No psychiatric illness or social situation that would preclude study compliance
• No grade 2 or greater sensory or motor neuropathy
• No prior allergic reactions attributed to compounds of similar chemical or biological composition to erlotinib
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• At least 3 weeks since prior immunologic therapy for SCC of the cervix
• One additional prior cytotoxic chemotherapy regimen for recurrent or persistent disease allowed
• At least 3 weeks since prior chemotherapy for SCC of the cervix and recovered
• No prior non-cytotoxic chemotherapy for recurrent or persistent disease
• At least 3 weeks since prior hormonal therapy for SCC of the cervix
• At least 3 weeks since prior radiotherapy for SCC of the cervix and recovered
• Recovered from recent prior surgery
• At least 3 weeks since other prior therapy for SCC of the cervix
• No prior epidermal growth factor receptor-targeting therapies
• No prior anticancer treatment that would preclude study participation
• No other concurrent investigational or commercial agents or therapies for SCC of the cervix