Erlotinib and Carboplatin in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Brief Title

Erlotinib and Carboplatin in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Official Title

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

Brief Summary

      RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor
      cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop
      tumor cells from dividing so they stop growing or die. Combining erlotinib with carboplatin
      may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining erlotinib and carboplatin in
      treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.

Detailed Description

OBJECTIVES:

- 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.

Study Phase

Phase 2

Study Type

Interventional

Condition

Fallopian Tube Cancer

Intervention

carboplatin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

January 10, 2002

Completion Date

December 21, 2009

Primary Completion Date

February 11, 2005

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  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

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  ECOG 0-2

        Life expectancy:

          -  At least 12 weeks

        Hematopoietic:

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

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

        Hepatic:

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

          -  AST/ALT no greater than 2.5 times ULN

        Renal:

          -  Creatinine no greater than ULN

        Cardiovascular:

          -  No symptomatic congestive heart failure

          -  No unstable angina

          -  No cardiac arrhythmia

        Gastrointestinal:

          -  See Surgery

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

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

          -  No active peptic ulcer disease

        Ophthalmic:

          -  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
                  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)

        Other:

          -  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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  See Disease Characteristics

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

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

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

        Surgery:

          -  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

        Other:

          -  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

Gender

Female

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Hal W. Hirte, MD, FRCP(C), ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT00030446

Organization ID

I149

Secondary IDs

CAN-NCIC-149

Responsible Party

Sponsor

Study Sponsor

NCIC Clinical Trials Group

Study Sponsor

Hal W. Hirte, MD, FRCP(C), Study Chair, Margaret and Charles Juravinski Cancer Centre

Verification Date

April 2020