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Home > "E" Clinical Trials Conditions > Erlotinib and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer  Erlotinib and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Erlotinib and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
For Condition: peritoneal cavity cancer,Fallopian Tube Cancer,recurrent ovarian epithelial cancer
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: 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 recurrentovarian, fallopian tube, or primaryperitoneal cancer.
Details: 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, vs platinum-resistant, defined as less than 6 months since prior therapy with platinum agent [stratum temporarily closed to accrual as of 12/4/2002]). 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 and 15-30 for platinum-resistant stratum [temporarily closed to accrual as of 12/4/2002]) will be accrued for this study within 15-23 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HalHirte, Study Chair, Margaret and Charles Juravinski Cancer Centre
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Amit Oza 416-946-2818
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Hal Hirte 905-387-9495 ext. 64601
Hopital Notre- Dame du CHUM *Recruiting*
Montreal, Quebec, H4L 2M1
Canada
Recruiting Diane Provencher 514-890-8200
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Ian Kerr 519-685-4006
Queen Elizabeth II Health Science Centre *Recruiting*
Halifax, Nova Scotia, B3H 2Y9
Canada
Recruiting Robert Grimshaw 902-473-4029
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting Kenneth Swenerton 604-877-6000 ext. 2365
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Prafull Ghatage 403-944-1721
British Columbia Cancer Agency - Centre for the Southern Interior *Recruiting*
Kelowna, British Columbia, V1Y 5L3
Canada
Recruiting Marianne Taylor 250-712-3996
Additional Information:
Study ID Numbers: CDR0000069166; CAN-NCIC-149,CAN-NCIC-IND149
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030446
Other Fallopian Tube Cancer Studies:
1. Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
2. Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
3. Combination Chemotherapy and Surgery in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
4. Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
5. PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer
Related Studies:
Other Fallopian Tube Cancer Clinical Trials
Other British Columbia Clinical Trials
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Erlotinib and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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