Bendamustine and Bevacizumab for Advanced Cancers
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
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: April 25, 2013
Last verified: April 2013
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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) [ Time Frame: Every 28 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 55 |
| Study Start Date: | June 2010 |
| Estimated Primary Completion Date: | June 2016 (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:
Drug: Bevacizumab
10 mg/kg by vein on Days 1 & 15 of every 28 day cycle
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 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 Criteria:
- 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.
Contacts and Locations
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 |
| Study First Received: | June 25, 2010 |
| Last Updated: | April 25, 2013 |
| 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 May 23, 2013