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Phase I Study of Cisplatin Plus OSI-7904L in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT00116896
Recruitment Status : Completed
First Posted : July 1, 2005
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: OSI-7904L Drug: Cisplatin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of OSI-7904L in Combination With Cisplatin in Patients With Advanced Solid Tumors
Study Start Date : June 2003
Estimated Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Advanced and/or metastatic solid tumor for which no effective therapy is available
  • ECOG performance status 0-2
  • Adequate bone marrow, hepatic and renal function

Exclusion Criteria:

  • Patients with active or uncontrolled infections
  • Neurotoxicity >= Grade 2
  • Symptomatic brain metastases which are not stable
Contacts and Locations

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): NCT00116896


Locations
United States, Tennessee
Vanderbilt Universtiy Medical Center
Nashville, Tennessee, United States, 37232-6307
United States, Texas
Institute for Drug DevelopmentCancer Therapy & Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
OSI Pharmaceuticals
More Information

ClinicalTrials.gov Identifier: NCT00116896     History of Changes
Other Study ID Numbers: OSI-904-102
First Posted: July 1, 2005    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: November 2003

Additional relevant MeSH terms:
Cisplatin
Antineoplastic Agents