A Phase II Evaluation Of OSI-774 (NSC #718781) In The Treatment Of Persistent or Recurrent Squamous Cell Carcinoma Of The Cervix
Overview
- Phase
- Phase 2
- Intervention
- erlotinib hydrochloride
- Conditions
- Cervical Squamous Cell Carcinoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the antitumor cytostatic activity of OSI-774 as measured by the probability of surviving progression-free for at least 6 months in patients with persistent or recurrent squamous cell carcinoma of the cervix. II. To determine the nature and degree of toxicity of OSI-774 in this cohort of patients. SECONDARY OBJECTIVES: I. To determine the partial and complete response rates in patients with squamous cell carcinoma of the cervix receiving OSI-774. II. To determine the duration of progression-free survival and overall survival within this patient population treated with OSI-774. III. Assess the effects of prognostic factors: initial performance status and age. TERTIARY OBJECTIVES: I. To determine epidermal growth factor receptor (EGFR) and p110 truncated EGFR (p110 sEGFR) isoform expression levels in primary tumors, and from tumor samples obtained pretreatment and following four weeks of therapy to determine tumor response (or resistance) to OSI-774 inhibition of the EGFR tyrosine kinase. II. To correlate EGFR and p110sEGFR expression levels with either MAPK or AKT phosphorylation status in the same tissue samples obtained pretreatment and following four weeks of drug treatment to determine downstream effects with response to OSI-774 inhibition of EGFR. III. To determine whether pretreatment serum p110 sEGFR concentrations are a useful prognostic indicator and whether altered and/or sEGFR concentrations are useful indicators of therapeutic responsiveness, time to progression, and overall survival in cervical carcinoma patients. OUTLINE: This is a multicenter study. Patients receive oral erlotinib once daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Investigators
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)
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: erlotinib hydrochloride
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.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: At 6 months
Frequency and severity of adverse effects as measured by NCI CTC version 3.0
Time Frame: Up to 5 years
Secondary Outcomes
- Duration of overall survival(Up to 5 years)
- Duration of progression-free survival(Up to 5 years)
- Frequency of clinical response (complete and partial)(Up to 5 years)
- Prognostic factors including initial performance status and age(Up to 5 years)