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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00031993
First received: March 8, 2002
Last updated: January 16, 2013
Last verified: January 2013
  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


Condition Intervention Phase
Cervical Squamous Cell Carcinoma
Recurrent Cervical Cancer
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation Of OSI-774 (NSC #718781) In The Treatment Of Persistent or Recurrent Squamous Cell Carcinoma Of The Cervix

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as measured by NCI CTC version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Duration of progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency of clinical response (complete and partial) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Prognostic factors including initial performance status and age [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: March 2002
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: erlotinib hydrochloride
Given PO
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031993

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: Russell Schilder Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031993     History of Changes
Other Study ID Numbers: NCI-2012-02457, GOG-0227D, U10CA027469, CDR0000069247
Study First Received: March 8, 2002
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014