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

Sponsor

NCIC Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00030446

Collaborator

(none)

Enrollment

Locations

95.3

Actual Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	Drug: carboplatin Drug: erlotinib hydrochloride	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 10, 2002

Actual Primary Completion Date :

Feb 11, 2005

Actual Study Completion Date :

Dec 21, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2
2	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia	Canada	V1Y 5L3
3	British Columbia Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6
4	Queen Elizabeth II Health Science Centre	Halifax	Nova Scotia	Canada	B3H 2Y9
5	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
6	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
7	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
8	Hopital Notre- Dame du CHUM	Montreal	Quebec	Canada	H4L 2M1