Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies
This study is currently recruiting participants.
Verified December 2012 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01113476
First received: April 28, 2010
Last updated: December 27, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The goal of this clinical research study is to find the highest tolerable dose of the combination of Abraxane (nab-paclitaxel), Gemzar (gemcitabine), and Avastin (bevacizumab) that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Drug: Nab-paclitaxel Drug: Bevacizumab Drug: Gemcitabine |
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: | Phase I Study of Combination of Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies |
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: With each 28 day cycle ] [ Designated as safety issue: Yes ]A MTD is defined as the dose level below the dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT) in the first cycle.
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nab-paclitaxel, Gemcitabine + Bevacizumab
Starting doses of Nab-paclitaxel 50 mg/m^2, Bevacizumab 5 mg/kg + fixed dose of Gemcitabine 1000 mg/m^2
|
Drug: Nab-paclitaxel
Starting dose of 50 mg/m^2 on Day 1, 8 + 15 every 28 days (+/- 2 days)
Other Names:
Drug: Bevacizumab
Starting dose of 5 mg/m^2 on Day 1 + 15 every 28 days (+/- 2 days)
Other Names:
Drug: Gemcitabine
1000 mg/kg Day 1, 8 + 15 every 28 days (+/- 2 days)
Other Names:
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a complete response (CR) rate of at least 10% or improves survival by at least three months.
- Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
- The Eastern Cooperative Oncology Group (ECOG) performance status </= 2 (Karnofsky >/= 60%).
- Patients must have allowable organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/=50,000/mL; creatinine </= 3 * upper limit of normal (ULN); total bilirubin </= 3.0; ALT(SGPT) </= 5 * ULN; fasting level of total cholesterol of no more than 350mg/dL; triglyceride level of no more than 400mg/dL.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies.
Exclusion Criteria:
- Patients with hemoptysis within 28 days prior to entering the study.
- Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.
- Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140mmHg, diastolic blood pressure > 90 mmHg on medication).
- Pregnant or lactating women.
- History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
- History of hypersensitivity to gemcitabine
- History of hypersensitivity to nab-paclitaxel or paclitaxel
- Patients with clinically significant cardiovascular disease: Myocardial Infarction or unstable angina pectoris within the last 6 months, Class III/IV NYHA heart failure
- History of cerebrovascular accident (CVA) within 6 months
- History of surgery within last 28 days.
- Grade 3/4 proteinuria
- Nephrotic syndrome
- Incompletely healed wound.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113476
Contacts
| Contact: David S. Hong, MD | 713-794-1226 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: David S. Hong, MD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | David S. Hong, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01113476 History of Changes |
| Other Study ID Numbers: | 2009-0855 |
| Study First Received: | April 28, 2010 |
| Last Updated: | December 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Malignancies Nab-paclitaxel Gemcitabine Bevacizumab |
Additional relevant MeSH terms:
|
Neoplasms Antibodies, Monoclonal Gemcitabine Bevacizumab Paclitaxel Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Radiation-Sensitizing Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013