Erlotinib in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Cervical Squamous Cell Carcinoma, Recurrent Cervical Cancer
About this trial
This is an interventional treatment trial for Cervical Squamous Cell Carcinoma
Eligibility Criteria
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
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.