Status:
COMPLETED
MK-0646, Etoposide, and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
NCIC Clinical Trials Group
Collaborating Sponsors:
Merck Frosst Canada Ltd.
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as MK-0646, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or car...
Detailed Description
OBJECTIVES: * To determine the recommended phase II dose of MK-0646 in combination with a standard etoposide and cisplatin chemotherapy regimen in patients with extensive stage small cell lung cancer...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Extensive stage disease that is incurable but amenable to treatment with platinum-based chemotherapy
- Small cell and variant histologies allowed
- No mixed tumors (i.e., small and large cell) or other neuroendocrine tumors of the lung
- Clinically and/or radiologically documented measurable disease, defined as ≥ 1 unidimensionally measurable site of disease ≥ 20 mm by chest x-ray, ≥ 15 mm by CT scan (lymph nodes), or ≥ 10 mm by CT scan or physical exam
- No uncontrolled or symptomatic CNS metastases
- Patients who have completed radiotherapy or have undergone complete resection of CNS metastases are allowed provided they are on stable (non-increasing) or decreasing doses of corticosteroids
- PATIENT CHARACTERISTICS:
- Life expectancy ≥ 12 weeks
- ECOG performance status 0-2
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN (≤ 5 times ULN if documented liver metastases)
- Serum creatinine ≤ ULN OR creatinine clearance ≥ 50 mL/min
- Not pregnant or lactating
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after completion of study therapy
- No other active cancer
- No untreated and/or uncontrolled cardiovascular or other comorbid conditions
- Patients with a significant cardiac history, even if controlled, should have a LVEF \> 50%
- No uncontrolled diabetes
- Must be accessible for treatment and follow-up
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior cytotoxic chemotherapy or other IGF-1R targeting agents for SCLC
- At least 3 weeks since prior radiotherapy to neurological sites
- No prior radiotherapy to the lungs
- Prior surgery allowed provided that wound healing has occurred
- At least 14 days since prior major surgery
- No other concurrent investigational agents or therapy
- No other concurrent anticancer treatment
- No concurrent radiotherapy
Exclusion
Key Trial Info
Start Date :
December 16 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00869752
Start Date
December 16 2009
End Date
July 4 2012
Last Update
August 4 2023
Active Locations (3)
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1
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
2
Ottawa Health Research Institute - General Division
Ottawa, Ontario, Canada, K1H 8L6
3
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9