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Phase II Trial Of Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes

Phase 2
18 Years
75 Years
Open (Enrolling)
Sarcoma, Leiomyosarcoma, Malignant Fibrous, Histiocytoma, Angiosarcoma

Thank you

Trial Information

Phase II Trial Of Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

is to determine the 6 month progression free rate for sarcoma patients treated with bevacizumab combined with gemcitabine and docetaxel.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

William Tap, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2009

Completion Date:

April 2013

Related Keywords:

  • Sarcoma
  • Leiomyosarcoma
  • Malignant Fibrous
  • Histiocytoma
  • Angiosarcoma
  • Bevacizumab (avastin)
  • Gemcitabine
  • Taxotere (docetaxel)
  • 09-015
  • Soft tissue
  • Histiocytoma
  • Hemangiosarcoma
  • Leiomyosarcoma
  • Sarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021