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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
N/A
Not Enrolling
Both
Small Cell Lung Cancer

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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:

Interventional

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

Authority:

United States: Food and Drug Administration

Study ID:

0402

NCT ID:

NCT00116610

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

Name

Location

University of Kansas Medical CenterKansas City, Kansas  66160-7353
Southwest Regional Cancer CenterAustin, Texas  78705
Georgia Cancer SpecialistsDecatur, Georgia  30033
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534
Genesis Cancer CenterHot Springs, Arkansas  71913
South Carolina Oncology Associates, PAColumbia, South Carolina  29210
Comprehensive Cancer CenterGlendale, California  91204
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Augusta Oncology AssociatesAugusta, Georgia  30901
Providence Portland Medical CenterPortland, Oregon  97213-3635
Oncology Hematology Group of South FloridaMiami, Florida  33176
Medical Center of VincennesVincennes, Indiana  47591
Hematology Oncology Centers of the Northern RockiesBillings, Montana  59101
Louisiana State University Health Science CenterNew Orleans, Louisiana  70112
The West ClinicMemphis, Tennessee  38120
Consultants in Medical Oncology & HematologyDrexel Hill, Pennsylvania  19026
Mt. Sinai Medical CenterNew York, New York  10029
The Center for Cancer Care & ResearchSt. Louis, Missouri  63141
Rush Medical CollegeChicago, Illinois  60612
Study SiteLos Angeles, California  
Eastern Connecticut Hematology/OncologyNorwich, Connecticut  06360
Central Georgia Hematology Oncology AssociatesMacon, Georgia  31201
Markey Cancer Center, University of KentuckyLexington, Kentucky  40536
The Ochsner ClinicNew Orleans, Louisiana  70121-2483
University of Missouri / Ellis Fischel Cancer CenterColumbia, Missouri  65203-3299
V.A. Sierra Nevada Health CareReno, Nevada  89502
Dartmouth-Hitchcock Medical Center Hematology/OncologyLebanon, New Hampshire  03756