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

Primary Purpose

Cervical Squamous Cell Carcinoma, Recurrent Cervical Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
erlotinib hydrochloride
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Treatment (erlotinib hydrochloride)

Arm Description

Patients receive oral erlotinib once daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Progression-free survival
Frequency and severity of adverse effects as measured by NCI CTC version 3.0

Secondary Outcome Measures

Duration of overall survival
Duration of progression-free survival
Frequency of clinical response (complete and partial)
Prognostic factors including initial performance status and age

Full Information

First Posted
March 8, 2002
Last Updated
January 16, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00031993
Brief Title
Erlotinib in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Official Title
A Phase II Evaluation Of OSI-774 (NSC #718781) In The Treatment Of Persistent or Recurrent Squamous Cell Carcinoma Of The Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Squamous Cell Carcinoma, Recurrent Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (erlotinib hydrochloride)
Arm Type
Experimental
Arm Description
Patients receive oral erlotinib once daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
CP-358,774, erlotinib, OSI-774
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
At 6 months
Title
Frequency and severity of adverse effects as measured by NCI CTC version 3.0
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Duration of overall survival
Time Frame
Up to 5 years
Title
Duration of progression-free survival
Time Frame
Up to 5 years
Title
Frequency of clinical response (complete and partial)
Time Frame
Up to 5 years
Title
Prognostic factors including initial performance status and age
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Schilder
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

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

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