Status:
COMPLETED
Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer
Lead Sponsor:
Poniard Pharmaceuticals
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II research study that is designed for patients who have small cell lung cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a new platinum-based...
Detailed Description
Platinum drugs work by binding to DNA and preventing the rapid cell division of tumors. However, many tumors demonstrate a resistance to platinum drugs. Results from preclinical studies indicate that ...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Diagnosis of small cell lung cancer.
- Patients must have had one prior chemotherapy regimen which must have included either cisplatin or carboplatin.
- \[Additional eligibility criteria apply.\]
- Exclusion Criteria:
- Prior radiotherapy that included \> 30% of the bone marrow (i.e., the whole of the pelvis or half of the spine).
- Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
- Significant heart disease.
- Uncontrolled, untreated, unstable, or symptomatic brain tumors or central nervous system disease.
- Grade 2+ peripheral neuropathy (a condition caused by damage to the nerves in the peripheral nervous system).
- \[Additional exclusion criteria apply.\]
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2008
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00116610
Start Date
June 1 2005
End Date
March 1 2008
Last Update
January 21 2009
Active Locations (55)
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1
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
2
Study Site
Los Angeles, California, United States
3
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
4
Eastern Connecticut Hematology/Oncology
Norwich, Connecticut, United States, 06360