Bendamustine and Bevacizumab for Advanced Cancers

NCT01152203 | Completed Phase 1

• 2 other identifiers: 2009-0979NCI-2010-01690
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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 combination will also be studied.

Conditions

Advanced Cancer

Keywords

Bendamustine; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Bendamustine and Bevacizumab

  MTD defined as highest dose below any dose that has one third or more patients with dose limiting toxicity (DLT). If not more than 33% of the patients in the cohort develop DLT, this cohort considered MTD. DLT defined as any Grade 3 or 4 non-hematologic toxicity as defined in most current version of NCI Common Toxicity Criteria for Adverse Effects (CTCAE).

  28 days

Study Arms (1)

Bendamustine + Bevacizumab

EXPERIMENTAL

Bendamustine starting dose of 70 mg/m\^2 by vein on Days 1 and 2 of a 28 day cycle. Bevacizumab 10 mg/kg by vein on Days 1 \& 15 of every 28 day cycle.

Drug: Bendamustine; Drug: Bevacizumab

Interventions

Bendamustine DRUG

Starting dose of 70 mg/m\^2 by vein on Days 1 and 2 of a 28 day cycle

Also known as: Bendamustine hydrochloride, Bendamustine HCI, CEP-18083, SDX-105, Treanda

Bendamustine + Bevacizumab

Bevacizumab DRUG

10 mg/kg by vein on Days 1 \& 15 of every 28 day cycle

Also known as: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

Bendamustine + Bevacizumab

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Cephalon: collaborator
• National Comprehensive Cancer Network: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Bendamustine Hydrochloride; Bevacizumab

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Apostolia M. Tsimberidou, MD, PhD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 18, 2015

Record last verified: 2014-05

Locations

US (1)