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

NCT00030446 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: I149CAN-NCIC-149CDR0000069166
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 8

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; fallopian tube cancer; peritoneal cavity cancer

Interventions

carboplatin DRUG

erlotinib hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (8)

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Queen Elizabeth II Health Science Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Notre- Dame du CHUM

Montreal, Quebec, H4L 2M1, Canada

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hal W. Hirte, MD, FRCP(C)

  Margaret and Charles Juravinski Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: June 27, 2003
• Study Start: January 10, 2002
• Primary Completion: February 11, 2005
• Study Completion: December 21, 2009
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)