NCT01876082

PAZOPANIB Efficacy and Tolerance in Desmoids Tumors

PAZOPANIB Efficacy and Tolerance in Desmoids Tumors : Phase 2 Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Desmoids tumors are benign soft tissues tumors characterized by aggressiveness and potential local recurrence. There is a female predominance with a sex ratio of 2/1 and median age at diagnosis is about 30 years. Only a complete surgical excision is recommended in desmoids tumors. Some forms of desmoid tumors are recurrent and/or symptomatic and are not accessible to a conservative surgical treatment. In these clinical situations, only a medical treatment may achieve tumor control and quality of life maintenance. Place of systemic treatments in the management of desmoids tumors is poorly evaluated. Regarding chemotherapy, methotrexate and vinblastine protocol is actually the best evaluated combination, which allowed observing objective response rate between 40 and 75%. Toxicity was mainly marked by the risk of haematological toxicity. Pazopanib is an inhibitor of multi-target tyrosine kinase, in oral form, with selective type receptors -1, -2 and -3 of VEGF receptors on the PDGFA and B, and c-Kit. It is currently under clinical development in humans in the treatment of several tumor types.

Detailed description

This is a Phase II, randomized, multicenter, open label trial, evaluating efficacy and safety of pazopanib versus a chemotherapy protocol combining methotrexate and vinblastine in progressive and symptomatic desmoid tumors. This study will include 72 patients in 15 centers of the French Sarcoma Group. Patients will be treated according to therapeutic strategy allocated by randomization until documented RECIST progression and for a maximum of 12 months : * Arm A = experimental strategy: daily oral administration of pazopanib. * Arm B = reference strategy: methotrexate-vinblastine. In case of documented radiological progression (RECIST criteria): * Patients initially included in arm A will have the opportunity, as determined by the investigator, to receive arm B treatment, or leave the study, * Patients initially included in arm B will have the opportunity, as determined by the investigator, to receive arm A treatment, or leave the study.

Conditions

• Progressive Desmoids Tumors

Interventions

Type	Name	Description
DRUG	PAZOPANIB treatment	Pazopanib * 800 mg per day * oral administration * at least 1 hour before or 2 hours after a meal, * until disease progression or for 12 months maximum
DRUG	Active Comparator: Vinblastine and Methotrexate	Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.

Timeline

• Start date: 2012-09-18
• Primary completion: 2018-03-01
• Completion: 2019-09-01
• First posted: 2013-06-12
• Last updated: 2025-09-04
• Results posted: 2021-03-05

Locations

1 site across 1 country: France