Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)
This study is currently recruiting participants.
Verified March 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01183663
First received: August 13, 2010
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
The goal of this clinical research study is to find the highest tolerable doses of the combinations of lenalidomide and other drugs that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancers |
Drug: Lenalidomide Drug: Bevacizumab Drug: Sorafenib Drug: Temsirolimus Drug: Oxaliplatin Drug: Leucovorin Drug: 5-fluorouracil |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-fluorouracil, Leucovorin, Oxaliplatin (FOLFOX) in Patients With Advanced Cancers |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Cancer
Drug Information available for:
Fluorouracil
Leucovorin calcium
Sirolimus
Oxaliplatin
Levoleucovorin
Everolimus
Temsirolimus
Lenalidomide
Bevacizumab
Sorafenib
Sorafenib tosylate
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX) [ Time Frame: Each cycle (21/28 days) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 180 |
| Study Start Date: | August 2010 |
| Estimated Primary Completion Date: | August 2025 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lenalidomide + Bevacizumab
Lenalidomide starting dose: 10 mg by mouth daily for 21 days of a 28 day cycle. Bevacizumab starting dose: 5 mg/kg by vein every 2 weeks of a 28 day cycle.
|
Drug: Lenalidomide
Starting dose 10 mg by mouth daily for 21 days of a 28 day cycle.
Other Names:
Drug: Bevacizumab
Starting dose: 5 mg/kg by vein every 2 weeks of a 28 day cycle.
Other Names:
|
|
Experimental: Lenalidomide + Sorafenib
Lenalidomide starting dose: 10 mg by mouth daily for 21 days of a 28 day cycle. Sorafenib starting dose: 200 mg by mouth daily for 28 a day cycle.
|
Drug: Lenalidomide
Starting dose 10 mg by mouth daily for 21 days of a 28 day cycle.
Other Names:
Drug: Sorafenib
Starting dose: 200 mg by mouth daily for 28 a day cycle.
Other Names:
|
|
Experimental: Lenalidomide + Temsirolimus
Lenalidomide starting dose: 10 mg by mouth daily for 21 days of a 28 day cycle. Temsirolimus starting dose: 15 mg by vein every week for a 28 day cycle.
|
Drug: Lenalidomide
Starting dose 10 mg by mouth daily for 21 days of a 28 day cycle.
Other Names:
Drug: Temsirolimus
Starting dose: 15 mg by vein every week for a 28 day cycle.
Other Names:
|
|
Experimental: Lenalidomide + Oxaliplatin + Leucovorin + 5-fluorouracil
Lenalidomide starting dose: 5 mg by mouth daily for 14 days of a 21 day cycle. Oxaliplatin starting dose: 65 mg/m2 by vein on day 1 of a 21 day cycle. Leucovorin 400 mg/m2 by vein on day 1 of a 21 day cycle. 5-fluorouracil 400 mg/m2 by vein through ambulatory pump on days 1-2 of a 21 day cycle.
|
Drug: Lenalidomide
Starting dose: 5 mg by mouth daily for 14 days of a 21 day cycle.
Other Names:
Drug: Oxaliplatin
Starting dose: 65 mg/m2 by vein on day 1 of a 21 day cycle.
Other Name: Eloxatin
Drug: Leucovorin
400 mg/m2 by vein on day 1 of a 21 day cycle.
Other Names:
Drug: 5-fluorouracil
400 mg/m2 by vein through ambulatory pump on days 1-2 of a 21 day cycle.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with advanced or metastatic cancer that is refractory to standard therapy, has relapsed after standard therapy, or for which there is no standard therapy available.
- Patients must be >/= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, therapeutic radiation, or major surgery. After targeted or biologic therapy there should be 5 half-lives or three weeks, whichever is shorter. Patients may have received palliative localized radiation immediately before or during treatment, providing radiation is not delivered only to the site of disease being treated under this protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2
- Patients must have normal organ and marrow function, defined as absolute neutrophil count >/= 1,000/mL; platelets >/=50,000/mL (unless these abnormalities are due to bone marrow involvement); creatinine clearance >/= 50 ml/min by Cockcroft-Gault formula; total bilirubin </= 2.0; and alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase(SGPT) </= 5 X ULN (unless patient has liver metastases).
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
- Patients must be able to understand and be willing to sign a written informed consent document.
- Must be >/= 18 years of age.
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Use of any other experimental drug or therapy within 21 days of baseline.
- Known hypersensitivity to thalidomide.
- History of hypersensitivity to any component of the formulation.
- The development of erythema nodosum, if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Patients unwilling or unable to sign informed consent document.
- Uncontrolled systemic vascular hypertension (Systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg on medication) for patients treated in the bevacizumab or sorafenib arms.
- Patients with active deep venous thrombosis or pulmonary embolism or patients receiving anti-coagulation.
- Patients with clinically significant cardiovascular disease: History of cerebro-vascular accident (CVA) within 6 months; Myocardial infarction or unstable angina within 6 months; Unstable angina pectoris.
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 of protocol treatment.
- Patients that are taking CYP3A4 inducers and/or inhibitors, being considered for the temsirolimus arm: If a patient has a history of taking CYP3A4 inducers and/or inhibitors prior to enrollment on the temsirolimus arm, it is strongly recommended that the patient stops the drug and waits at least 5 half-lives of said drug before initiating therapy on the temsirolimus arm.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183663
Contacts
| Contact: Apostolia M. Tsimberidou, MD, PhD | 713-792-4259 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Apostolia M. Tsimberidou, MD, PhD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
| Principal Investigator: | 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: | NCT01183663 History of Changes |
| Other Study ID Numbers: | 2010-0108 |
| Study First Received: | August 13, 2010 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Lenalidomide Bevacizumab Sorafenib Temsirolimus 5-Fluorouracil Leucovorin Oxaliplatin Avastin Anti-VEGF monoclonal antibody rhuMAB-VEGF CC-5013 Revlimid Nexavar BAY 43-90006 Metastatic cancer |
Metastatic colorectal cancer Advanced solid tumors Hematologic malignancies Colon cancer Advanced colorectal cancer Breast cancer Pancreatic cancer Gastric cancer Advanced renal cell carcinoma Prostate cancer Melanoma Unresectable hepatocellular carcinoma Renal cell carcinoma Metastatic breast cancer Glioblastoma |
Additional relevant MeSH terms:
|
Neoplasms Antibodies Antibodies, Monoclonal Fluorouracil Sirolimus Everolimus Thalidomide Oxaliplatin Bevacizumab Lenalidomide Sorafenib Leucovorin Levoleucovorin Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents Antibiotics, Antineoplastic Antifungal Agents |
ClinicalTrials.gov processed this record on May 16, 2013