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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Detroit, Michigan, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboplatin + SU011248 (sunitinib) + paclitaxel

Drug

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.

Other names: Paraplatin; SUTENT; Taxol

Primary outcomes

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)

Time frame: 3 yrs

Secondary outcomes

Evaluate pharmacokinetic parameters of carboplatin, paclitaxel, SU011248 and its active metabolite, SU012662. Assess antitumor activity of the combination.

Time frame: 3 yrs

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2009
Study completion: 2009
First posted: Aug 6, 2007
Registry last updated: Feb 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed