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
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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