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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
carboplatin
erlotinib hydrochloride
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Tom Baker Cancer Center - Calgary
  • British Columbia Cancer Agency - Centre for the Southern Interior
  • British Columbia Cancer Agency
  • Queen Elizabeth II Health Science Centre
  • Margaret and Charles Juravinski Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Princess Margaret Hospital
  • Hopital Notre- Dame du CHUM

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
April 6, 2020
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00030446
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2002 (Actual)
Primary Completion Date
February 11, 2005 (Actual)
Study Completion Date
December 21, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hal W. Hirte, MD, FRCP(C)
Organizational Affiliation
Margaret and Charles Juravinski Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
British Columbia Cancer Agency - Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Queen Elizabeth II Health Science Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Notre- Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4L 2M1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Hirte H, Oza A, Hoskins P, et al.: Phase II study of OSI-774 given in combination with carboplatin in patients (pts) with recurrent epithelial ovarian cancer (EOC): NCIC CTG IND.149. [Abstract] European Journal of Cancer Supplements 1 (5): A-159, S51, 2003.
Results Reference
result

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

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