Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes

NCT00887809 | Completed Phase 2 Results DMC

• 1 other identifier: 09-015
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test whether an experimental drug called bevacizumab given together with gemcitabine and docetaxel, a standard chemotherapy regimen for sarcoma, can help sarcoma patients. This trial will examine what effects, good and/or bad the combination of gemcitabine, docetaxel and bevacizumab has on sarcoma.

Conditions

Sarcoma; Leiomyosarcoma; Malignant Fibrous; Histiocytoma; Angiosarcoma

Keywords

Bevacizumab (avastin); Gemcitabine; Taxotere (docetaxel); 09-015; Soft tissue

Outcome Measures

Primary Outcomes (1)

• Overall Objective Response

  Overall Objective Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)

  6 months

Study Arms (1)

gemcitabine and docetaxel with bevacizumab

EXPERIMENTAL

Patients will receive bevacizumab at 15 mg/kg on day 1 of each 21-day cycle intravenously over 30 minutes followed by a one hour (+30/-15 min) break. For cycles 1 through 6, gemcitabine will be administered at 900 mg/m2 over 90 minutes on day 1 and 8 of a 21-day cycle. Docetaxel will be administered at 75 mg/m2, over 60 minutes, on day 8. This will be followed by either 5 days of filgrastim or a single injection of pegfilgrastim. For cycles 7 and beyond, gemcitabine will be given at 800 mg/m2 over 30 minutes on day 1 and 8; docetaxel will be given at 35 mg/m2 over 30 minutes, also on days 1 and 8.

Drug: gemcitabine; Drug: docetaxel; Drug: bevacizumab

Interventions

gemcitabine DRUG

gemcitabine and docetaxel with bevacizumab

docetaxel DRUG

gemcitabine and docetaxel with bevacizumab

bevacizumab DRUG

gemcitabine and docetaxel with bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed unresectable metastatic or locally recurrent leiomyosarcoma, Malignant Fibrous Histiocytoma (MFH, also known as high grade Undifferentiated Pleomorphic Sarcoma) pleomorphic liposarcoma, rhabdomyosarcoma or angiosarcoma.
• Zero to one prior chemotherapy regimens for metastatic disease. Prior adjuvant therapy will not count provided it was more than one year previously.
• Measurable disease as defined by RECIST
• Adequate performance status - ECOG 0 or 1
• Patients must be recovered from the toxic effects of prior chemotherapy or radiation. Therapy may not start until at least 3 weeks since prior cytotoxic chemotherapy, two weeks from completion of radiation therapy, and one week for patients on tyrosine kinase inhibitors or other targeted therapy.
• Age 18 To 75. As it is quite difficult to administer high dose docetaxel with gemcitabine, to the elderly, in order to protect patient safety, we will restrict eligibility to patients between the ages of 18 and 75.
• Adequate hematologic, hepatic and renal function as defined below
• Hemoglobin \> or = to 8.0 g/dl
• Absolute neutrophil count \> or = to 1,500/mm3
• Platelet count \> or = to 100,000/mm3
• Total Bilirubin \< or = to1.5 x upper limit of normal (ULN).
• ALT (SGOT) or AST (SGPT) \< or = to 5 x ULN.
• Alkaline Phosphatase \< or = to 2.5 x ULN or ≤ 5 x ULN in presence of liver metastases.
• Serum creatinine 2.0 mg/dL
• Ability to understand informed consent and comply with treatment protocol

You may not qualify if:

• Uncontrolled intercurrent illness including infection or congestive heart failure within 6 months.
• Prior therapy with gemcitabine, docetaxel or bevacizumab
• Patients receiving other investigational agents
• Patients with known brain metastases
• Pregnancy or unwillingness to use effective birth control
• Patients with HIV disease will be permitted, only if they are on effective anti-retroviral therapy, have a CD4 count greater than 400, and have had no opportunistic infections within the past 6 months.
• Patients on anti-coagulation will be permitted if they are on a stable dose of warfarin or low-molecular weight heparin, and have had no major bleeds within the past 6 months.
• Inability to comply with study and/or follow-up procedures.
• Life expectancy of less than 12 weeks.
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
• Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last three years
• Inadequately controlled hypertension (defined as systolic blood pressure \> 150 and/or diastolic blood pressure \> 100 mmHg lasting \> 24 hours on antihypertensive medications)
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection), requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Sarcoma; Leiomyosarcoma; Histiocytoma; Hemangiosarcoma

Interventions

Gemcitabine; Docetaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Vascular Tissue

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

Results Point of Contact

• Title: Dr. William Tap
• Organization: Memorial Sloan Kettering Cancer Center

tapw@mskcc.org

646-888-4163

Study Officials

• William Tap, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 25, 2016
• Results First Posted: January 25, 2016

Record last verified: 2015-12

Locations

US (1)