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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Closed

18 and over

Pharmaceutical / Industry

0402
IND No. 69,507, NCT00116610

Trial Description

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.

Further Study Information

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.

Eligibility 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.]

Trial Contact Information

Trial Lead Organizations/Sponsors

Poniard Pharmaceuticals, Incorporated

Hazel Breitz, MD

Study Director

Paul Weiden, MD

Study Director

David Karlin, MD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00116610
Information obtained from ClinicalTrials.gov on May 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.