Bevacizumab in Multiple Phase I Combinations
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00543504
First received: October 11, 2007
Last updated: March 29, 2013
Last verified: March 2013
- 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 Avastin™ that can be given in combination with 4 other study drug/drug combinations. It will be given with sunitinib, with sorafenib, with a combination of erlotinib and cetuximab, and with a combination of trastuzumab and lapatinib. The safety and effectiveness of these drug combinations will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Drug: Bevacizumab Drug: Sorafenib Drug: Erlotinib Drug: Trastuzumab Drug: Lapatinib Drug: Sunitinib Drug: Cetuximab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study of Bevacizumab in Combination With 1) Sunitinib, 2) Sorafenib, 3) Erlotinib and Cetuximab, 4) Trastuzumab and Lapatinib |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Malic acid
Trastuzumab
Erlotinib hydrochloride
Erlotinib
Cetuximab
Bevacizumab
Lapatinib
Sorafenib
Sunitinib malate
Lapatinib Ditosylate
Sorafenib tosylate
Sunitinib
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- MTD (Maximum Tolerable Dose) of Avastin in combination with 4 other study drug/drug combinations [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]MTD defined by Dose Limiting Toxicity in first 28 day cycle (induction phase)
| Estimated Enrollment: | 354 |
| Study Start Date: | October 2007 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bevacizumab + Sunitinib
Arm 1: Bevacizumab starting dose 2.5 mg/kg intravenous (IV) over 90 minutes + Sunitinib 12.5 mg orally daily for 4 weeks, then 2 weeks off.
|
Drug: Bevacizumab
2.5 mg/kg By Vein Over 90 Minutes.
Other Names:
Drug: Sunitinib
12.5 mg orally daily for 4 weeks, then 2 weeks off.
Other Names:
|
|
Experimental: Bevacizumab + Sorafenib
Arm 2: Bevacizumab starting dose 2.5 mg/kg intravenous (IV) over 90 minutes + Sorafenib 200 mg by mouth daily for 28 Days
|
Drug: Bevacizumab
2.5 mg/kg By Vein Over 90 Minutes.
Other Names:
Drug: Sorafenib
200 mg By Mouth Daily for 28 Days
Other Name: BAY 43-9006
|
|
Experimental: Bevacizumab + Erlotinib + Cetuximab
Arm 3: Bevacizumab starting dose 2.5 mg/kg intravenous (IV) over 90 minutes + Erlotinib 50 mg By Mouth Daily for 28 Days + Cetuximab loading dose 100 mg/m² IV and maintenance 75 mg/m² on Days 1, 8, 15, 22.
|
Drug: Bevacizumab
2.5 mg/kg By Vein Over 90 Minutes.
Other Names:
Drug: Erlotinib
50 mg By Mouth Daily for 28 Days.
Other Names:
Drug: Cetuximab
Loading 100 mg/m² by vein and Maintenance 75 mg/m² by vein on Days 1, 8, 15, 22
|
|
Experimental: Bevacizumab + Trastuzumab + Lapatinib
Arm 4: Bevacizumab starting dose 2.5 mg/kg intravenous (IV) over 90 minutes + Trastuzumab loading dose 2 mg/kg IV then maintenance dose 1 mg/kg IV on Day 1 + Lapatinib 250 mg By Mouth Daily for 21 Days.
|
Drug: Bevacizumab
2.5 mg/kg By Vein Over 90 Minutes.
Other Names:
Drug: Trastuzumab
Loading 2 mg/kg by vein then Maintenance 1 mg/kg by vein on Day 1
Other Name: Herceptin
Drug: Lapatinib
250 mg By Mouth Daily for 21 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 must be three weeks from prior cytotoxic therapy; if they have recovered their blood counts to eligibility levels sooner and have no mucositis or other acute toxicities, they may be treated earlier but no sooner than two weeks after their last chemotherapy. Patients must be two weeks or five half lives from biologic therapy, whichever is shorter.
- The Eastern Cooperative Oncology Group (ECOG) performance status </= 2 (Karnofsky >/= 60%).
- Patients must have normal organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/=75,000/mL; creatinine </= 3 * upper limits of normal (ULN); total bilirubin </= 2.0; Alanine transaminase (ALT)(Serum Glutamic Pyruvate Transaminase (SGPT)) </= 3 * ULN; Exception for patients with liver metastasis: total bilirubin </= 3 * ULN; ALT(SGPT) </= 5 * ULN. Exception for the bevacizumab + erlotinib + cetuximab arm and the bevacizumab + trastuzumab + lapatinib arm: no minimum absolute neutrophil count or platelet count.
- The effects of bevacizumab on the developing human fetus are unknown. Angiogenesis is of critical importance to fetal development, and bevacizumab is likely to have adverse consequences in terms of fetal development. For this reason, 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 30 days after the last dose.
- Ability to understand and the willingness to sign a written informed consent document.
- Life expectancy of at least 3 months.
- Patients with a prior ep vein thrombosis (DVT)/pulmonary embolism (PE) are eligible for treatment if they are receiving or have finished receiving appropriate anticoagulation therapy.
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 > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).
- Patients with clinically significant cardiovascular disease: history of CVA within 6 months, myocardial infarction or unstable angina within 6 months, or unstable angina pectoris.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
- Pregnant or lactating women.
- History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
- (For patients on the sunitinib treatment arm and the trastuzumab/lapatinib treatment arm only) Left ventricular ejection fraction of less than 50% unless the patient is receiving an angiotensin-converting enzyme (ACE) inhibitor / angiotensin receptor blocker (ARB) and a beta-blocker.
- (For sorafenib treatment arm only) Hypersensitivity to sorafenib or any component of the formulation.
- (For erlotinib and cetuximab treatment arm only) History of hypersensitivity to erlotinib or any component of the formulation.
- (For erlotinib and cetuximab treatment arm only) History of hypersensitivity to cetuximab, murine products, or any component of the formulation.
- (For trastuzumab and lapatinib treatment arm only) History of hypersensitivity to trastuzumab, Chinese hamster ovary cell proteins, or any component of the formulation.
- (For trastuzumab and lapatinib treatment arm only) History of hypersensitivity to lapatinib or any component of the formulation.
- Patients with clinically significant gastrointestinal bleeding within 28 days prior to entering the study.
- Patients with hemorrhagic brain metastases.
- Patients with prior abdominal surgery within 30 days prior to entering the study.
- (For patients on the sunitinib treatment arm and the trastuzumab/lapatinib treatment arm only) Left ventricular ejection fraction of less than 50%, unless the patient is receiving an angiotensin-converting enzyme (ACE) inhibitor / angiotensin receptor blocker (ARB) and a beta-blocker.
- (For patients on the sunitinib treatment arm and the trastuzumab/lapatinib treatment arm only) QTc prolongation, defined as greater than 440 milliseconds for males, and greater than 460 milliseconds for females.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543504
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Gerald Falchook, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00543504 History of Changes |
| Other Study ID Numbers: | 2006-0638 |
| Study First Received: | October 11, 2007 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Cancer Bevacizumab Avastin Sorafenib BAY 43-9006 Erlotinib OSI-774 Tarceva Trastuzumab Herceptin Sunitinib |
SU011248 Sutent Cetuximab Lapatinib Tykerb Anti-VEGF monoclonal antibody rhuMAb-VEGF Erlotinib hydrochloride GW572016 Sunitinib Malate |
Additional relevant MeSH terms:
|
Neoplasms Antibodies Antibodies, Monoclonal Trastuzumab Bevacizumab Cetuximab Sorafenib Sunitinib Lapatinib Erlotinib Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013