Combination Chemotherapy for Advanced Cancer
Trial Summary
What is the purpose of this trial?
The goal of this clinical research study is to find the highest tolerable dose of the combination of bevacizumab (Avastin) and temsirolimus (Torisel) that can be given with 1 of 3 other study drugs --carboplatin (Paraplatin), paclitaxel (Taxol), or sorafenib (Nexavar). The safety of these drug combinations will also be studied.
Will I have to stop taking my current medications?
The trial requires that you stop taking previous chemotherapy or radiotherapy for three weeks before joining, and six weeks if the therapy has delayed toxicity. Additionally, medications that strongly affect the enzyme P450 3A4 should be avoided within five half-lives of temsirolimus.
What data supports the effectiveness of the drug combination of Bevacizumab, Carboplatin, and Paclitaxel for advanced cancer?
The combination of Bevacizumab, Carboplatin, and Paclitaxel has been shown to improve overall survival in patients with advanced non-small cell lung cancer, as demonstrated in a clinical trial where patients receiving this combination lived longer than those receiving only Carboplatin and Paclitaxel.12345
What safety information is available for the combination chemotherapy treatment involving Bevacizumab, Carboplatin, and Paclitaxel?
The combination of Bevacizumab, Carboplatin, and Paclitaxel has been associated with serious side effects such as high blood pressure, bleeding, and infections. Some patients may experience severe complications like gastrointestinal perforation (a hole in the stomach or intestines), wound healing issues, and blood clots. Common side effects include fatigue, nausea, and headache.46789
How is the drug combination of Bevacizumab, Carboplatin, Paclitaxel, Sorafenib, and Temsirolimus unique for treating advanced cancer?
This drug combination is unique because it combines multiple agents that target cancer in different ways, including Bevacizumab, which inhibits blood vessel growth in tumors, and Temsirolimus, which blocks a protein that helps cancer cells grow. This multi-faceted approach may offer benefits over standard treatments that typically use fewer drugs.510111213
Research Team
Shannon Westin, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with advanced or metastatic cancer that's resistant to standard treatments, relapsed, or without beneficial standard options. Participants must have stable vital signs and organ function, not be on other experimental drugs, and agree to use contraception. Excluded are pregnant women, those with recent surgery or significant cardiovascular issues, uncontrolled hypertension, certain allergies to the study drugs or their components.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination of bevacizumab and temsirolimus with either carboplatin, paclitaxel, or sorafenib. The treatment cycles are 21 or 28 days long, depending on the drug combination.
Dose Escalation
Participants are assigned to dose levels to determine the maximum tolerated dose. Dose escalation continues until the highest tolerable dose is found.
Follow-up
Participants are monitored for safety and effectiveness after treatment. CT or MRI scans are performed every 2-3 cycles, and after 6 months, every 4 cycles if deemed necessary.
Treatment Details
Interventions
- Bevacizumab
- Carboplatin
- Paclitaxel
- Sorafenib
- Temsirolimus
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor