Study With Pazopanib in Combination With Cisplatin (CDDP) in Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this research is to evaluate the potential interest of an association of Pazopanib, a multi-tyrosine kinase inhibitor, and cisplatin.

As cisplatin has marketing approval for several cancers (ovarian, testicle, bladder, esophagus, endometrium, lung, stomach, head and neck cancer (HNC)), and in order to have a rapid evaluation of this combination, we will evaluate the combination in any patient whose tumors is known to be sensible to cisplatin (except tumors at risk of bleeding).

This study is a classical phase 1 trial of pazopanib and 3-weekly cisplatin association. It will allow for optimal dose selection and pharmacokinetic analysis. It is planed to include around 38 patients, enriching the optimal tolerated regimen (OTR) level only with a cohort of triple negative breast cancer patients. If the association is proven to be feasible, we will then move to a specific phase II study in triple negative breast cancer patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Cisplatin

Criteria

Main Inclusion Criteria:

• Documented metastatic solid malignancies for patients who are candidate to receive a cisplatin based regimen.

• During the dose seeking procedure : ALL solid tumors

• During the Optimal Tolerated Regimen validation procedure : ONLY HER2-RH- breast cancer

• Measurable or evaluable disease

• WHO performance status ≤ 1

• Negative dipstick proteinuria test or if positive proteinuria <1g/24h. If proteinuria appears ≥ 2+ on routine dipstick testing, patients must undergo a 24H -urine collection and demonstrate proteinuria < 1g/24H

• Corrected QT interval (QTc) ≤ 480 msecs using Bazett's formula

Main Exclusion Criteria:

• Prior treatment with cisplatin reaching a cumulative dose> 300 mg/m2

• HER2 positive breast cancer

• Patients at high risk of bleeding

• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product

• calcium and magnesium levels inferior to standard levels (measured within 14 days before the first pazopanib dose) and potassium levels inferior to standard levels (measured within 72 hours before the first pazopanib dose)

• Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study

• Hearing impairment/tinnitus > or = grade 2