A Study To Find The Best Dose Of SU011248 When Given With Pemetrexed, Pemetrexed And Cisplatin Or Pemetrexed And Carboplatin In Patients With Advanced Solid Tumors
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00528619
First received: September 10, 2007
Last updated: April 7, 2011
Last verified: April 2011
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Cancer
Drug Information available for:
Cisplatin
Carboplatin
Pemetrexed
Pemetrexed disodium
Sunitinib malate
Sunitinib
U.S. FDA Resources
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 plasma pharmacokinetics of SU011248 and its metabolite, SU012662 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/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 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/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 ]
| Enrollment: | 96 |
| Study Start Date: | November 2006 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
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.
Other Name: Sutent, SU011248, Alimta, Platinol, Paraplatin
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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.
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: NCT00528619
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528619
Locations
| United States, Colorado | |
| Pfizer Investigational Site | |
| Aurora, Colorado, United States, 80045 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2L 4M1 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00528619 History of Changes |
| Other Study ID Numbers: | A6181084 |
| Study First Received: | September 10, 2007 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Solid tumor malignancy non-small cell lung cancer sunitinib |
pemetrexed Phase 1 Mesothelioma |
Additional relevant MeSH terms:
|
Sunitinib Cisplatin Pemetrexed Carboplatin Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on September 26, 2016