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Monoclonal Antibodies
Combination Chemotherapy for Advanced Cancer
Phase 1
Waitlist Available
Led By Shannon Westin, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status </= 2 (Karnofsky >/= 60%, Lansky >/= 50%)
Patients must have normal organ function as defined
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days
Awards & highlights
Study Summary
This trial is testing different combinations of drugs to see what the highest tolerable dose is for each one. They will also be studying the safety of each combination.
Who is the study for?
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.Check my eligibility
What is being tested?
Researchers are testing the highest dose of Bevacizumab (Avastin) and Temsirolimus (Torisel) that can be safely given with one of three other drugs: Carboplatin (Paraplatin), Paclitaxel (Taxol), or Sorafenib (Nexavar). The aim is to determine safety and tolerability of these combinations in treating advanced cancers.See study design
What are the potential side effects?
Potential side effects include high blood pressure from Bevacizumab; mouth sores, rash from Temsirolimus; nerve damage from Paclitaxel; fatigue from Carboplatin; skin reactions from Sorafenib. Each drug may also cause unique side effects affecting different organs and overall health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do active work.
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My organs are functioning normally.
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My blood cell counts are normal and I have minimal nerve damage.
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My bone marrow functions normally.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Anti-Tumor Efficacy of Temsirolimus and Bevacizumab When Used in Combination with Carboplatin
Anti-Tumor Efficacy of Temsirolimus and Bevacizumab When Used in Combination with Paclitaxel
Anti-Tumor Efficacy of Temsirolimus and Bevacizumab When Used in Combination with Sorafenib
Trial Design
3Treatment groups
Experimental Treatment
Group I: Sorafenib GroupExperimental Treatment3 Interventions
Sorafenib: Starting dose 200 mg by mouth daily for a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
Group II: Paclitaxel GroupExperimental Treatment3 Interventions
Paclitaxel: Starting dose 30 mg/m2 given by vein on day 1 of a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
Group III: Carboplatin GroupExperimental Treatment3 Interventions
Carboplatin: Starting dose AUC 2 by vein on day 1 of a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Temsirolimus
2008
Completed Phase 2
~1940
Sorafenib
2014
Completed Phase 3
~1670
Bevacizumab
2013
Completed Phase 4
~5280
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,503 Total Patients Enrolled
Shannon Westin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
195 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart condition.I am allergic to carboplatin or its ingredients.I am not taking strong drugs that affect liver enzyme P450 3A4 within a certain period before starting temsirolimus.I do not have an active infection needing IV antibiotics.My high blood pressure is not under control.I have bleeding in brain tumors.I had surgery in my belly area recently.I can take care of myself but might not be able to do active work.My organs are functioning normally.I am not on any experimental drugs or cancer treatments, except for hormone therapy.My blood cell counts are normal and I have minimal nerve damage.My bone marrow functions normally.I have had unexplained bleeding recently.I am not allergic to paclitaxel or its ingredients.My advanced cancer hasn't responded to standard treatments or has come back.I have not had chemotherapy or radiotherapy for a certain period.I am allergic to sorafenib or its ingredients.I agree to use birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Carboplatin Group
- Group 2: Sorafenib Group
- Group 3: Paclitaxel Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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