Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer
- Conditions
- Small Cell Lung Cancer
- Registration Number
- NCT00116610
- Lead Sponsor
- Poniard Pharmaceuticals
- 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 agent that is currently under investigation, in 21-day cycles.
- 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 picoplatin (previously called AMD473 or ZD0473) may be able to overcome or partially overcome platinum resistance. More than 500 patients have received picoplatin in previous Phase I or Phase II clinical trials.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Not provided
- 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.]
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Comprehensive Cancer Center
🇺🇸Palm Springs, California, United States
Study Site
🇺🇸Los Angeles, California, United States
Augusta Oncology Associates
🇺🇸Augusta, Georgia, United States
The Center for Cancer Care & Research
🇺🇸St. Louis, Missouri, United States
Mt. Sinai Medical Center
🇺🇸New York, New York, United States
Consultants in Medical Oncology & Hematology
🇺🇸Drexel Hill, Pennsylvania, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Tom Baker Cancer Center
🇨🇦Calgary, Alberta, Canada
Central Georgia Hematology Oncology Associates
🇺🇸Macon, Georgia, United States
Georgia Cancer Specialists
🇺🇸Tucker, Georgia, United States
Rush Medical College
🇺🇸Chicago, Illinois, United States
Medical Center of Vincennes
🇺🇸Vincennes, Indiana, United States
Southeastern Medical Oncology Center
🇺🇸Goldsboro, North Carolina, United States
University of Missouri / Ellis Fischel Cancer Center
🇺🇸Columbia, Missouri, United States
Louisiana State University Health Science Center
🇺🇸Shreveport, Louisiana, United States
South Carolina Oncology Associates, PA
🇺🇸Columbia, South Carolina, United States
Oncology Hematology Group of South Florida
🇺🇸Miami, Florida, United States
Dartmouth-Hitchcock Medical Center Hematology/Oncology
🇺🇸Lebanon, New Hampshire, United States
Hematology Oncology Centers of the Northern Rockies
🇺🇸Billings, Montana, United States
V.A. Sierra Nevada Health Care
🇺🇸Reno, Nevada, United States
The Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Markey Cancer Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
Eastern Connecticut Hematology/Oncology
🇺🇸Norwich, Connecticut, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States