Phase IB Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma

Phase 1

Completed

• Conditions: Sarcoma
• Interventions: Drug: Gemcitabine, Docetaxel and Bevacizumab

• Registration Number: NCT00276055
• Lead Sponsor: New Mexico Cancer Care Alliance

Brief Summary

1.1 To determine the recommended phase II dose for gemcitabine in combination with a fixed dose of docetaxel and bevacizumab.

1.2 To determine the efficacy of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma 1.3 To determine the toxicity profile of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma

Detailed Description

Because the combination of gemcitabine and docetaxel has shown impressive activity in soft tissue sarcoma, we hypothesize that the addition of an antiangiogenesis agent (bevacizumab) would enhance the anticancer activity, as shown in other tumor types.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-12
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients with symptomatic brain metastases are excluded from this study.
• Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
• Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
• Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	Gemcitabine, Docetaxel and Bevacizumab	1000mg/m2 gemcitabine
Cohort 2	Gemcitabine, Docetaxel and Bevacizumab	1250 mg/m2 gemcitabine
Cohort 3	Gemcitabine, Docetaxel and Bevacizumab	1500 mg/m2 gemcitabine

Primary Outcome Measures

Name	Time	Method
Overall response rate (complete and partial responses).	4 years	Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). ORR is the sum of the percentages of patients achieving complete and partial responses

Trial Locations

Locations (4)

Hematology Oncology Associates; 🇺🇸 Albuquerque, New Mexico, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

St. Vincent Regional Medical Center; 🇺🇸 Santa Fe, New Mexico, United States

New Mexico Cancer Care Associates; 🇺🇸 Santa Fe, New Mexico, United States