Bendamustine and Bevacizumab for Advanced Cancers

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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 combination will also be studied.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Cephalon; National Comprehensive Cancer Network
• Treatments: Bendamustine Hydrochloride; Bevacizumab

Criteria

Inclusion Criteria:

1. Patients must have histologically confirmed cancer.

2. Patients should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival by at least 3 months.

3. 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).

4. Adequate renal function (serum creatinineFiltration Rate (GFR) >/= 40 mL/min if creatinine > 2.0 mg/dL). Pediatric: serum creatinine

5. Hepatic function: total bilirubinhave a total bilirubinpatient has liver metastases, total bilirubinof normal.

6. 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.

7. 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.

8. 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.

9. Must be >/= 13 years of age.

10. Sign informed consent. Pediatric participants: age 13-17 would sign assent, parent or guardian would sign consent.

Exclusion Criteria:

1. Pregnant females.

2. Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.

3. Serious or non-healing wound, ulcer or bone fracture.

4. Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg).

5. 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.

6. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.

7. Patients with clinical bleeding, active gastric or duodenal ulcer.

8. Patients with history of bleeding central nervous system (CNS) metastasis will be excluded from the trial.

9. Patients with major surgery within 28 days prior to entering the study.