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

This study has been completed.
Sponsor:
Information provided by:
Poniard Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00116610
First received: June 29, 2005
Last updated: January 19, 2009
Last verified: February 2007
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
Drug: picoplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Poniard Pharmaceuticals:

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

Estimated Enrollment: 75
Study Start Date: June 2005
Study Completion Date: March 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.]

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116610

  Show 55 Study Locations
Sponsors and Collaborators
Poniard Pharmaceuticals
Investigators
Study Director: Hazel Breitz, MD Poniard Pharmaceuticals
Study Director: Paul Weiden, MD Poniard Pharmaceuticals
Study Director: David Karlin, MD Poniard Pharmaceuticals
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00116610     History of Changes
Other Study ID Numbers: 0402, IND No. 69,507
Study First Received: June 29, 2005
Last Updated: January 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Poniard Pharmaceuticals:
small cell lung cancer
resistant
refractory
platinum
chemotherapy
second-line
relapse
sensitive

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014