Status:
COMPLETED
Bendamustine and Bevacizumab for Advanced Cancers
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Cephalon
National Comprehensive Cancer Network
Conditions:
Advanced Cancer
Eligibility:
All Genders
13+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest tolerable combination dose of bendamustine and bevacizumab that can be given to patients with advanced cancer. The safety of the drug co...
Detailed Description
The Study Drugs: Bendamustine is designed to damage DNA (the genetic material) of cancer cells. Bendamustine also interferes with the creation of new DNA, which may keep cancer cells from repairing t...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed cancer.
- Patients should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival by at least 3 months.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self care but unable to carry out any work activities). Pediatric: performance status Karnovsky (\>10) or Lansky (\<10).
- Adequate renal function (serum creatinine \</= 2.0 mg/dL or the calculated Glomerular Filtration Rate (GFR) \>/= 40 mL/min if creatinine \> 2.0 mg/dL). Pediatric: serum creatinine \</= 1.5 mg/dL or 2x upper limit of normal, for age.
- Hepatic function: total bilirubin \</= 1.0 mg/dL (Patients with Gilbert's Syndrome must have a total bilirubin \</= 3.0 mg/dL); ALT \</= 3 times upper limit of normal. If patient has liver metastases, total bilirubin \</= 5 mg/dL; ALT \</= 5 times upper limit of normal.
- Adequate bone marrow function (Absolute neutrophil count (ANC) \>/= 1,000 cells/uL; Platelets (PLT) \>/= 75,000 cells/uL), unless these abnormalities are due to bone marrow involvement.
- At least three weeks from previous cytotoxic chemotherapy. After targeted or biologic therapy there should be 5 half-lives or 3 weeks, whichever is shorter.
- All females in childbearing age MUST have a negative urine human chorionic gonadotropin (HCG) test unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity). Patients should not become pregnant or breast-feed while on this study. Sexually active patients should use effective birth control.
- Must be \>/= 13 years of age.
- Sign informed consent. Pediatric participants: age 13-17 would sign assent, parent or guardian would sign consent.
Exclusion
- Pregnant females.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Serious or non-healing wound, ulcer or bone fracture.
- Uncontrolled systemic vascular hypertension (systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg).
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parental antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.
- Patients with clinical bleeding, active gastric or duodenal ulcer.
- Patients with history of bleeding central nervous system (CNS) metastasis will be excluded from the trial.
- Patients with major surgery within 28 days prior to entering the study.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01152203
Start Date
June 1 2010
End Date
May 1 2014
Last Update
November 18 2015
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030