Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors

Neoplasms Clinical Trial

Official title:

Phase I Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511849
• Other study ID #: A6181050
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2007
• Last updated: February 16, 2010
• Start date: November 2005
• Est. completion date: February 2009

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test SU011248 (sunitinib) in combination with paclitaxel/carboplatin. This combination regimen will be tested for safety and antitumor activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically proven diagnosis of any advanced solid malignancy that is not amenable to treatment with curative intent

• Candidates for treatment with carboplatin and paclitaxel with maximum of 2 prior chemotherapy regimens

• ECOG performance status 0 or 1

Exclusion Criteria:

• Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target, metastatic lesions

• Diagnosis of any second malignancy within the past 3 years

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• carboplatin + SU011248 (sunitinib) + paclitaxel
AUC of 6 mg*min/mL administered as a 30-minute infusion, every 21 days for 4 cycles or until progression/unacceptable toxicity. 25 mg, 37.5 mg, or 50 mg (depending on the dose level assigned) orally taken every day or for 2 weeks and 1 week off without for 4 cycles or until progression/unacceptable toxicity. 175 mg/m2, 200 mg/m2, or 225 mg/m2 (depending on the dose level assigned), administered as a 3-hour infusion every 21 days for 4 cycles or until progression/unacceptable toxicity.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the maximum tolerated dose (MTD) and overall safety of SU011248 when administered in combination with paclitaxel/carboplatin in patients with advanced solid tumors (ongoing)		3 yrs	No
Secondary	Evaluate pharmacokinetic parameters of carboplatin, paclitaxel, SU011248 and its active metabolite, SU012662. Assess antitumor activity of the combination.		3 yrs	No

External Links

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