Expired Study
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Philadelphia, Pennsylvania 19103


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

NCI-2012-02457


NCT ID:

NCT00031993


Secondary ID:

GOG-0227D


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

51


Enrollment Type:

Actual


Overall Contact Information

Official Name:Russell Schilder
Principal Investigator
Gynecologic Oncology Group

Study Dates

Start Date:March 2002
Primary Completion Date:November 2005
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 16, 2013
First Received Date:March 8, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:Progression-free survival
Time Frame:At 6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Frequency and severity of adverse effects as measured by NCI CTC version 3.0
Time Frame:Up to 5 years
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Duration of overall survival
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Duration of progression-free survival
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Frequency of clinical response (complete and partial)
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Prognostic factors including initial performance status and age
Time Frame:Up to 5 years
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:erlotinib hydrochloride
Description:Given PO
Arm Name:Treatment (erlotinib hydrochloride)
Other Name:CP-358,774
Intervention Type:Other
Name:laboratory biomarker analysis
Description:Correlative studies
Arm Name:Treatment (erlotinib hydrochloride)

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (erlotinib hydrochloride)
Description:Patients receive oral erlotinib once daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Schilder RJ, Sill MW, Lee YC, Mannel R. A phase II trial of erlotinib in recurrent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group Study. Int J Gynecol Cancer. 2009 Jul;19(5):929-33.
PMID:19574787

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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