Bendamustine and Bevacizumab for Advanced Cancers

This study has been completed.
Sponsor:
Collaborators:
Cephalon
National Comprehensive Cancer Network
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01152203
First received: June 25, 2010
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Advanced Cancer
Drug: Bendamustine
Drug: Bevacizumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Bendamustine and Bevacizumab for Patients With Advanced Cancers

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Bendamustine and Bevacizumab [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 59
Study Start Date: June 2010
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bendamustine + Bevacizumab
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
Starting dose of 70 mg/m^2 by vein on Days 1 and 2 of a 28 day cycle
Other Names:
  • Bendamustine hydrochloride
  • Bendamustine HCI
  • CEP-18083
  • SDX-105
  • Treanda
Drug: Bevacizumab
10 mg/kg by vein on Days 1 & 15 of every 28 day cycle
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  5. 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.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152203

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cephalon
National Comprehensive Cancer Network
Investigators
Study Chair: Apostolia M. Tsimberidou, MD, PhD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01152203     History of Changes
Other Study ID Numbers: 2009-0979, NCI-2010-01690
Study First Received: June 25, 2010
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Bendamustine
Bevacizumab

Additional relevant MeSH terms:
Neoplasms
Antibodies, Monoclonal
Bendamustine
Bevacizumab
Nitrogen Mustard Compounds
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014