Date First Received: September 10, 2007
Last Updated: April 9, 2008
Verified by: Pfizer, April 2008
Clinical Trial Phase: Phase 1 Start Date: November 2006
Overall Status: Recruiting
Estimated Enrollment: 100

Rationale

Intervention(s): Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin

This study will assess the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin in patients with advanced solid tumors.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Outcome Measures for this Clinical Trial

Primary
• To determine maximally tolerated dose of SU011248 (dosed continuously or on a 2/1 Schedule) when given in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin. From screening until at least 28 days beyond discontinuation of study treatment

Secondary
• To evaluate the pharmacokinetics of SU011248 and pemetrexed, SU011248, pemetrexed and cisplatin and SU011248, pemetrexed and carboplatin when these drugs are co-administered. From screening until disease progression or discontinuation of the study
• To preliminarily assess the antitumor activity of SU011248 and pemetrexed in non-small cell lung cancer patients. From screening until disease progression or discontinuation of the study
• To preliminarily assess the antitumor activity of SU011248, pemetrexed and cisplatin and SU011248, pemetrexed and carboplatin in patients with non-small cell lung cancer or advanced unresectable mesothelioma. From screening until disease progression or discontinuation of the study

Inclusion Criteria

• Patients with a diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists.

• Patient has a good performance status (ECOG 0 or 1).

Exclusion Criteria

• Prior treatment with either pemetrexed or SU011248.

• Coughing up blood within 4 weeks before starting study treatment (small amounts okay).

• Hypertension that cannot be controlled by medications.

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts: Pfizer CT.gov Call Center Study Director Pfizer

Overall Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com

Additional Information

Information obtained from ClinicalTrials.gov on April 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00528619
Study ID Number: A6181084
ClinicalTrials.gov Identifier: NCT00528619

Labels: ClinicalTrial