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

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin<br>* 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.<br>* Other names: Sutent, SU011248, Alimta, Platinol, Paraplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | From screening until disease progression or discontinuation of the study | 
| 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. |  | From screening until disease progression or discontinuation of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumor malignancy, non-small cell lung cancer, sunitinib, pemetrexed, Phase 1, Mesothelioma