Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00030446
Recruitment Status : Completed
First Posted : June 27, 2003
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : January 10, 2002
Actual Primary Completion Date : February 11, 2005
Actual Study Completion Date : December 21, 2009






Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030446


Locations
Layout table for location information
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Notre- Dame du CHUM
Montreal, Quebec, Canada, H4L 2M1
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Layout table for investigator information
Study Chair: Hal W. Hirte, MD, FRCP(C) Margaret and Charles Juravinski Cancer Centre

Publications of Results:
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.

Layout table for additonal information
Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00030446    
Other Study ID Numbers: I149
CAN-NCIC-IND149
CAN-NCIC-149
CDR0000069166 ( Other Identifier: PDQ )
First Posted: June 27, 2003    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Carboplatin
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action