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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

Must not have

Patients with clinically significant cardiovascular disease

For carboplatin treatment arm: Hypersensitivity to carboplatin or any component of the formulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I am allergic to carboplatin or its ingredients.

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My high blood pressure is not under control.

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I have had unexplained bleeding recently.

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I do not have an active infection needing IV antibiotics.

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I have bleeding in brain tumors.

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I am not allergic to paclitaxel or its ingredients.

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I am allergic to sorafenib or its ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6120

Temsirolimus

2008

Completed Phase 2

~1940