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

Completed · Phase 2

Conditions studied: Cervical Squamous Cell Carcinoma, Recurrent Cervical Cancer

In brief

This phase II trial is studying erlotinib to see how well it works in treating patients with persistent or recurrent cancer of the cervix. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor

Key facts

Study ID

NCT00031993

Run by

National Cancer Institute (NCI)

People needed

51

Starts

2002-03-01

Last updated by the study team

2013-01-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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