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A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

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Trial Information

A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium


OBJECTIVES:

- Determine the efficacy of erlotinib, in terms of response rate and duration of stable
disease, in patients with locally advanced and/or metastatic carcinoma of the
endometrium.

- Determine the toxicity of this drug in these patients.

- Determine the time to progression and duration of response in patients treated with
this drug.

- Correlate objective tumor response with levels of epidermal growth factor receptor
expression in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.

Patients are followed at 4 weeks. Patients with complete or partial response or stable
disease are also followed every 3 months until relapse or death.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic and/or locally advanced adenocarcinoma or
adenosquamous carcinoma of the endometrium

- Incurable by standard therapies

- Clinically and/or radiologically documented disease with at least 1 unidimensionally
measurable site

- At least 20 mm by x-ray, physical exam, or CT scan OR

- At least 10 mm by spiral CT scan

- Bone metastases considered nonmeasurable

- Tumor tissue from primary tumor available for assessing epidermal growth factor
receptor (EGFR) status

- No uterine sarcomas (leiomyosarcoma), mixed mullerian tumors, and/or adenosarcomas

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Platelet count at least 100,000/mm3

- Absolute granulocyte count at least 1,500/mm3

Hepatic:

- Bilirubin no greater than upper limit of normal (ULN)

- AST/ALT no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No symptomatic congestive heart failure

- No unstable angina

- No cardiac arrhythmia

Gastrointestinal:

- No gastrointestinal (GI) tract disease that would preclude ability to take oral
medication

- No requirement for IV alimentation

- No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)

- No active peptic ulcer disease

Ophthalmic:

- No significant ophthalmologic abnormalities, including any of the following:

- Prior severe dry eye syndrome, Sjogren's syndrome, or keratoconjunctivitis sicca

- Severe-exposure keratopathy

- Disorders that would increase the risk of epithelium-related complications
(e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic
keratitis)

- Congenital abnormality (e.g., Fuch's dystrophy)

- Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or
Bengal-Rose)

- Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear
production test)

- No concurrent ocular inflammation or infection

Other:

- No other malignancy within the past 5 years except adequately treated nonmelanoma
skin cancer or curatively treated carcinoma in situ of the cervix

- No prior allergic reaction attributed to compounds of similar biological or chemical
composition to erlotinib

- No other concurrent serious illness or medical condition that would preclude study

- No prior significant neurologic or psychiatric disorder that would preclude study

- No active uncontrolled infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for endometrial cancer

Endocrine therapy:

- No more than 1 prior hormonal therapy (progestational agent or aromatase inhibitor)
in the adjuvant or metastatic setting

- At least 1 week since prior hormonal therapy

Radiotherapy:

- At least 4 weeks since prior radiotherapy (except for low-dose palliative
radiotherapy) and recovered

Surgery:

- At least 3 weeks since prior major surgery and recovered

- No prior surgical procedures affecting absorption

- No concurrent ophthalmic surgery

Other:

- No prior EGFR-targeting therapies

- No other concurrent investigational therapy

- No other concurrent anticancer therapy

- Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased
vigilance with respect to monitoring INR

- Concurrent low molecular weight heparin allowed at investigator's discretion

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Amit M. Oza, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

United States: Federal Government

Study ID:

I148

NCT ID:

NCT00030485

Start Date:

January 2002

Completion Date:

January 2011

Related Keywords:

  • Endometrial Cancer
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

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