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A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer


- Determine the response rate in patients with recurrent ovarian epithelial, fallopian
tube, or primary peritoneal cancer treated with erlotinib and carboplatin.

- Determine the duration of stable disease, time to progression, and response duration in
patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

- Correlate the level of epidermal growth factor receptor tumor expression with objective
tumor response in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior
platinum-containing therapy (platinum-sensitive, defined as 6 months or more since prior
therapy with platinum agent [closed to accrual as of 2/13/2004], vs platinum-resistant,
defined as less than 6 months since prior therapy with platinum agent).

Patients receive carboplatin IV over 30 minutes on day 1 and oral erlotinib once daily on
days 1-21. Treatment repeats every 21 days for up to 6 courses. After the completion of 6
courses of therapy, patients with responsive or stable disease may continue to receive
erlotinib and carboplatin in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 23-60 patients (8-30 for platinum-sensitive stratum [closed to
accrual as of 2/13/2004] and 15-30 for platinum-resistant stratum) will be accrued for this
study within 15-23 months.

Inclusion Criteria


- Histologically confirmed recurrent ovarian epithelial, fallopian tube, or primary
peritoneal cancer for which no standard curative therapy exists

- At least 1 measurable lesion

- At least 20 mm by x-ray, non-spiral CT scan, or physical exam OR at least 10 mm
by spiral CT scan

- Ascites and bone metastases not considered measurable disease

- No abdominal adenocarcinoma of unknown origin or borderline ovarian tumor

- No elevated CA 125 as only evidence of disease

- At least 1 but no more than 2 prior chemotherapy regimens required

- First regimen must have contained cisplatin or carboplatin

- Switching platinum compounds due to disease progression or failure to respond is
considered 2 regimens

- Same regimen as first- and second-line therapy is considered 2 regimens

- Responded to prior platinum-based first-line chemotherapy

- No platinum-refractory disease

- No known brain metastases



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks


- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


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

- AST/ALT no greater than 2.5 times ULN


- Creatinine no greater than ULN


- No symptomatic congestive heart failure

- No unstable angina

- No cardiac arrhythmia


- See Surgery

- No GI tract disease resulting in an inability to take oral medication or requiring IV

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

- No active peptic ulcer disease


- No ocular inflammation or infection

- No significant ophthalmologic abnormalities, including:

- History of dry eye syndrome, Sjögren's syndrome, or keratoconjunctivitis sicca

- Severe exposure keratopathy

- Disorders that might increase the risk for epithelium-related complications
(e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic

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

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

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


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

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

- No other serious illness, medical condition, or significant neurologic or psychiatric
disorder that would preclude study therapy

- No active uncontrolled infection

- No grade 3 or greater drug-related neurotoxicity

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


Biologic therapy:

- Not specified


- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)

Endocrine therapy:

- Not specified


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


- At least 3 weeks since prior major surgery (wound healing must have occurred)

- No prior surgical procedures affecting gastrointestinal (GI) absorption

- No concurrent ophthalmic surgery


- No prior therapy targeting epidermal growth factor receptor

- No other concurrent anticancer therapy

- No other concurrent investigational agents

- Concurrent oral anticoagulants (e.g., warfarin) allowed provided INR is monitored

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Hal W. Hirte, MD, FRCP(C)

Investigator Role:

Study Chair

Investigator Affiliation:

Margaret and Charles Juravinski Cancer Centre


United States: Federal Government

Study ID:




Start Date:

January 2002

Completion Date:

December 2009

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms