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

NCT00276055 | Completed Phase 1 DMC

• 1 other identifier: INST 0509C
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

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

Conditions

Sarcoma

Keywords

Soft Tissue Sarcoma; Phase I; Gemcitabine; Docetaxel; Bevacizumab; vascular endothelial growth factor

Outcome Measures

Primary Outcomes (1)

• Overall response rate (complete and partial responses).

  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

  4 years

Study Arms (3)

Cohort 1

EXPERIMENTAL

1000mg/m2 gemcitabine

Drug: Gemcitabine, Docetaxel and Bevacizumab

Cohort 2

EXPERIMENTAL

1250 mg/m2 gemcitabine

Drug: Gemcitabine, Docetaxel and Bevacizumab

Cohort 3

EXPERIMENTAL

1500 mg/m2 gemcitabine

Drug: Gemcitabine, Docetaxel and Bevacizumab

Interventions

Gemcitabine, Docetaxel and Bevacizumab DRUG

During the treatment phase, pts. will receive the drug combination of gemcitabine, docetaxel, and bevacizumab every 2 weeks for a period of 4 weeks. This 4-week period is called a cycle of treatment. The treatment consists of receiving docetaxel IV over a 60-minute period and gemcitabine IV over a 30-minute period. Pts. will then receive bevacizumab IV over a 30-minute period. Pts. will receive this treatment once every 2 weeks. Pts. will receive at least 2 cycles of treatment unless you have progression of your disease or unmanageable side effects. As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment

Also known as: Taxotere, Gemzar, Avastin

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients, 18 years of age or older, with chemotherapy naive soft tissue sarcoma are eligible if there is measurable disease Prior surgery or radiotherapy for the primary tumor is allowed but needs to have been completed at least 2 weeks from entry, and patient should have completely recovered from the procedures.
• Patients must have a life expectancy of at least 12 weeks.
• Patients must have a Zubrod performance status of 0-2.
• Patients must sign an informed consent.
• Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,500 or cells/mm3 and platelet count \>100,000/mm3 and absence of a regular red blood cell transfusion requirement.
• Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (4)

Hematology Oncology Associates

Albuquerque, New Mexico, 87102-3661, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

St. Vincent Regional Medical Center

Santa Fe, New Mexico, 87505, United States

Location

New Mexico Cancer Care Associates

Santa Fe, New Mexico, 87508, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Gemcitabine; Docetaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Claire Verschraegen, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2006
• First Posted: January 12, 2006
• Study Start: November 1, 2005
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 19, 2015

Record last verified: 2015-06

Locations

US (4)