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A Phase II Evaluation Of OSI-774 (NSC #718781) In The Treatment Of Persistent or Recurrent Squamous Cell Carcinoma Of The Cervix

Phase 2
18 Years
Not Enrolling
Cervical Squamous Cell Carcinoma, Recurrent Cervical Cancer

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Trial Information

A Phase II Evaluation Of OSI-774 (NSC #718781) In The Treatment Of Persistent or Recurrent Squamous Cell Carcinoma Of The Cervix


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.


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.


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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

At 6 months

Safety Issue:


Principal Investigator

Russell Schilder

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

March 2002

Completion Date:

Related Keywords:

  • Cervical Squamous Cell Carcinoma
  • Recurrent Cervical Cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms



Gynecologic Oncology Group Philadelphia, Pennsylvania  19103