Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00887809
First received: April 23, 2009
Last updated: January 23, 2014
Last verified: January 2014

April 23, 2009
January 23, 2014
April 2009
April 2015   (final data collection date for primary outcome measure)
is to determine the 6 month progression free rate for sarcoma patients treated with bevacizumab combined with gemcitabine and docetaxel. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To determine if bevacizumab can increase progression free survival (PFS) when combined with gemcitabine and docetaxel. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00887809 on ClinicalTrials.gov Archive Site
  • To evaluate the effect of bevacizumab on RECIST response rate when combined with gemcitabine and docetaxel. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the effect of bevacizumab on response rate by alternative criteria (Choi) when combined with gemcitabine and docetaxel. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the effect of bevacizumab on overall survival when combined with gemcitabine and docetaxel. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the toxicity of bevacizumab, gemcitabine and docetaxel [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To evaluate the effect of bevacizumab on RECIST response rate when combined with gemcitabine and docetaxel. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the effect of bevacizumab on response rate by alternative criteria (Choi) when combined with gemcitabine and docetaxel. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the effect of bevacizumab on overall survival when combined with gemcitabine and docetaxel. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the effect of bevacizumab on 3 and 6 month PFS rates when combined with gemcitabine and docetaxel. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the toxicity of bevacizumab, gemcitabine and docetaxel compared with that of gemcitabine and docetaxel. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes
Phase II Trial Of Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sarcoma
  • Leiomyosarcoma
  • Malignant Fibrous
  • Histiocytoma
  • Angiosarcoma
Drug: gemcitabine and docetaxel with bevacizumab
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.
Experimental: 1 chemotherapy
gemcitabine and docetaxel with bevacizumab
Intervention: Drug: gemcitabine and docetaxel with bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • Normal cardiac ejection fraction
  • Urine protein:creatinine (UPC) ratio < than or = to 1.0 at screening

Exclusion Criteria:

  • 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
  • Symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  • Serious, non-healing wound, active ulcer, or non-healing bone fracture
  • Proteinuria at screening as demonstrated by
  • Urine protein:creatinine (UPC) ratio > or = to 1.0 at screening (patients discovered to have UPC ratio > or = to 1.0 at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
  • Known hypersensitivity to any component of bevacizumab
  • Pregnant (positive pregnancy test) or lactating. Use of effective means of contraception (men and women) in subjects of child-bearing potential
  • History of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 3 months prior to study enrollment.
  • Any history of stroke or transient ischemic attack within 6 months
  • History of myocardial infarction or unstable angina within 6 months
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00887809
09-015
Yes
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Genentech
Principal Investigator: William Tap, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP