Mesothelioma Related Clinical Trials:
Phase I Study of SU011248 in Combination With Pemetrexed, Pemetrexed/Cisplatin and Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies

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Status: Recruiting
Sponsors and Collaborators: Pfizer
Information provided by: Pfizer
Government Identifier: NCT00528619

Condition: Non-Small Cell Lung Cancer; Mesothelioma; Neoplasms
Intervention: Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin

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Purpose:


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
Official Title:   Phase I Study of SU011248 in Combination With Pemetrexed, Pemetrexed/Cisplatin and Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. [ Time Frame: From screening until at least 28 days beyond discontinuation of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetics of SU011248 and pemetrexed, SU011248, pemetrexed and cisplatin and SU011248, pemetrexed and carboplatin when these drugs are co-administered. [ Time Frame: From screening until disease progression or discontinuation of the study ] [ Designated as safety issue: No ]
  • To preliminarily assess the antitumor activity of SU011248 and pemetrexed in non-small cell lung cancer patients. [ Time Frame: From screening until disease progression or discontinuation of the study ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: From screening until disease progression or discontinuation of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:   100
Study Start Date:   November 2006
Estimated Study Completion Date:   May 2009

Arms Assigned Interventions
A: Experimental Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin
Dose finding study using Sunitinib daily by oral capsule in a continuous regimen or administered for 2 weeks out of every 3 weeks, with pemetrexed every 3 weeks or also with cisplatin 75 mg/m2 or carboplatin AUC=5 mg*min/mL until progression or unacceptable toxicity.

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Eligibility:

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528619

Contacts
Contact: Pfizer Oncology Clinical Trial Information Service     1-877-369-9753     PfizerCancerTrials@emergingmed.com    
Locations
United States, Colorado
Pfizer Investigational Site     Recruiting
      Aurora, Colorado, United States, 80012
Pfizer Investigational Site     Recruiting
      Aurora, Colorado, United States, 80045
Pfizer Investigational Site     Recruiting
      Denver, Colorado, United States, 80218
Canada, Ontario
Pfizer Investigational Site     Recruiting
      Ottawa, Ontario, Canada, K1H 8L6

Sponsors and Collaborators
Pfizer

Investigators
Study Director:     Pfizer CT.gov Call Center     Pfizer    

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Additional Information:

Responsible Party:   Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:   A6181084
First Received:   September 10, 2007
Last Updated:   February 1, 2008
ClinicalTrials.gov Identifier:   NCT00528619
Health Authority:   United States: Food and Drug Administration

Keywords provided by Pfizer:
Solid tumor malignancy, non-small cell lung cancer, sunitinib, pemetrexed, Phase 1  

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Carboplatin
Carcinoma
Folic Acid
Pemetrexed
Cisplatin
Lung Neoplasms
Sunitinib
Lung Diseases
Mesothelioma
Carcinoma, Non-Small-Cell Lung
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Mesothelioma
Antimetabolites
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Growth Inhibitors

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