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Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00116610
Recruitment Status : Completed
First Posted : June 30, 2005
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: picoplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer
Study Start Date : June 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.]


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116610


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Locations
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United States, Arkansas
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
United States, California
Study Site
Los Angeles, California, United States
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
United States, Connecticut
Eastern Connecticut Hematology/Oncology
Norwich, Connecticut, United States, 06360
United States, Florida
Oncology Hematology Group of South Florida
Miami, Florida, United States, 33176
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Augusta Oncology Associates
Augusta, Georgia, United States, 30901-5104
Central Georgia Hematology Oncology Associates
Macon, Georgia, United States, 31201
Georgia Cancer Specialists
Tucker, Georgia, United States, 30084
United States, Illinois
Rush Medical College
Chicago, Illinois, United States, 60612-3828
United States, Indiana
Medical Center of Vincennes
Vincennes, Indiana, United States, 47591
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
The Ochsner Clinic
New Orleans, Louisiana, United States, 70121-2483
Louisiana State University Health Science Center
Shreveport, Louisiana, United States, 71130-3932
United States, Missouri
University of Missouri / Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203-3299
The Center for Cancer Care & Research
St. Louis, Missouri, United States, 63141
United States, Montana
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, United States, 59101
United States, Nevada
V.A. Sierra Nevada Health Care
Reno, Nevada, United States, 89502
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Hematology/Oncology
Lebanon, New Hampshire, United States, 03756
United States, New York
Mt. Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534-9479
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Consultants in Medical Oncology & Hematology
Drexel Hill, Pennsylvania, United States, 19026
United States, South Carolina
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-6307
United States, Texas
Southwest Regional Cancer Center
Austin, Texas, United States, 78705
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Russian Federation
Stepanovskoye, Krasnogorskiy District, Moscow Region, Russian Federation
Ufa, Republic of Bashkortostan, Russian Federation
Petrozavodsk, Republic of Karelia, Russian Federation
Kazan, Republic of Tatarstan, Russian Federation
Izhevsk, Republic of Udmurtia, Russian Federation
Engels, Saratov Region, Russian Federation
Cherepovets, Vologodskaya Region, Russian Federation
Astrakhan, Russian Federation
Barnaul, Russian Federation
Chelyabinsk, Russian Federation
Ekaterinburg, Russian Federation
Kaliningrad, Russian Federation
Krasnodar, Russian Federation
Moscow, Russian Federation
Nizhny Novgorod, Russian Federation
Omsk, Russian Federation
Orenburg, Russian Federation
Pyatigorsk, Russian Federation
Rostov-na-Donu, Russian Federation
Samara, Russian Federation
St. Petersburg, Russian Federation
Stavropol, Russian Federation
Ulyanovsk, Russian Federation
Voronezh, Russian Federation
Yaroslavl, Russian Federation
Sponsors and Collaborators
Poniard Pharmaceuticals
Investigators
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Study Director: Hazel Breitz, MD Poniard Pharmaceuticals
Study Director: Paul Weiden, MD Poniard Pharmaceuticals
Study Director: David Karlin, MD Poniard Pharmaceuticals

Additional Information:
Publications:

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ClinicalTrials.gov Identifier: NCT00116610     History of Changes
Other Study ID Numbers: 0402
IND No. 69,507
First Posted: June 30, 2005    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: February 2007
Keywords provided by Poniard Pharmaceuticals:
small cell lung cancer
resistant
refractory
platinum
chemotherapy
second-line
relapse
sensitive
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms