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A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Small Cell Lung Cancer

Thank you

Trial Information

A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer

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.

Inclusion Criteria

Main inclusion criteria:

1. Diagnosis of small cell lung cancer.

2. 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.]

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)

Principal Investigator

Hazel Breitz, MD

Investigator Role:

Study Director

Investigator Affiliation:

Poniard Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

March 2008

Related Keywords:

  • Small Cell Lung Cancer
  • small cell lung cancer
  • resistant
  • refractory
  • platinum
  • chemotherapy
  • second-line
  • relapse
  • sensitive
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



University of Kansas Medical Center Kansas City, Kansas  66160-7353
Southwest Regional Cancer Center Austin, Texas  78705
Georgia Cancer Specialists Decatur, Georgia  30033
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Southeastern Medical Oncology Center Goldsboro, North Carolina  27534
Genesis Cancer Center Hot Springs, Arkansas  71913
South Carolina Oncology Associates, PA Columbia, South Carolina  29210
Comprehensive Cancer Center Glendale, California  91204
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Augusta Oncology Associates Augusta, Georgia  30901
Providence Portland Medical Center Portland, Oregon  97213-3635
Oncology Hematology Group of South Florida Miami, Florida  33176
Medical Center of Vincennes Vincennes, Indiana  47591
Hematology Oncology Centers of the Northern Rockies Billings, Montana  59101
Louisiana State University Health Science Center New Orleans, Louisiana  70112
The West Clinic Memphis, Tennessee  38120
Consultants in Medical Oncology & Hematology Drexel Hill, Pennsylvania  19026
Mt. Sinai Medical Center New York, New York  10029
The Center for Cancer Care & Research St. Louis, Missouri  63141
Rush Medical College Chicago, Illinois  60612
Study Site Los Angeles, California  
Eastern Connecticut Hematology/Oncology Norwich, Connecticut  06360
Central Georgia Hematology Oncology Associates Macon, Georgia  31201
Markey Cancer Center, University of Kentucky Lexington, Kentucky  40536
The Ochsner Clinic New Orleans, Louisiana  70121-2483
University of Missouri / Ellis Fischel Cancer Center Columbia, Missouri  65203-3299
V.A. Sierra Nevada Health Care Reno, Nevada  89502
Dartmouth-Hitchcock Medical Center Hematology/Oncology Lebanon, New Hampshire  03756