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Platinum-based Chemotherapy

Vorinostat + Chemotherapy for Advanced Cancer

Phase 1

Waitlist Available

Led By Michael L Maitland

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which no superior curative or palliative measures are known

At least 4 weeks must have passed since prior chemotherapy or radiation therapy; 6 weeks if the last regimen included BCNU or mitomycin C

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, vorinostat or carboplatin

Inability to swallow oral medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 (pre-treatment), 60, 120, 180, 240, 360 and 480 minutes and 24 hours after vorinostat administration on days 3 and 10 of course 0 and on day 3 of course 1

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying two different doses of vorinostat in combination with either carboplatin or paclitaxel to see which works better in treating patients with advanced solid tumors.

Who is the study for?

This trial is for patients with advanced solid tumors that can't be removed by surgery or have spread, and who haven't had chemotherapy or radiation in the last 4-6 weeks. They should have a life expectancy over 3 months, adequate organ function, and no severe illnesses that would limit study participation. Pregnant or breastfeeding women are excluded.

What is being tested?

The trial tests high-dose versus low-dose Vorinostat combined with Carboplatin or Paclitaxel to see which dosage is more effective at stopping tumor growth. The enzymes blocked by Vorinostat could help kill more cancer cells when used with these chemotherapy drugs.

What are the potential side effects?

Possible side effects include reactions related to the immune system, nerve damage causing numbness or tingling, muscle pain, changes in blood counts leading to increased infection risk, fatigue, nausea and vomiting from chemo drugs like Carboplatin and Paclitaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced, cannot be surgically removed, and has no better treatment options.

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It's been over 4 weeks since my last cancer treatment, or 6 weeks if it included BCNU or mitomycin C.

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My kidney function is normal or nearly normal.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I am allergic to medications similar to paclitaxel, vorinostat, or carboplatin.

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I cannot swallow pills.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I am not HIV-positive or not on antiretroviral therapy.

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I have used valproic acid before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 (pre-treatment), 60, 120, 180, 240, 360 and 480 minutes and 24 hours after vorinostat administration on days 3 and 10 of course 0 and on day 3 of course 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 (pre-treatment), 60, 120, 180, 240, 360 and 480 minutes and 24 hours after vorinostat administration on days 3 and 10 of course 0 and on day 3 of course 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (pre-treatment), 60, 120, 180, 240, 360 and 480 minutes and 24 hours after vorinostat administration on days 3 and 10 of course 0 and on day 3 of course 1 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Adverse events of two different escalated intermittent dosing schedules of vorinostat combined with carboplatin as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Pharmacodynamic markers of vorinostat activity, including AUC and changes in platelet counts

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Arm VI (mid- and low-dose vorinostat and paclitaxel)Experimental Treatment4 Interventions

Patients receive mid-dose vorinostat PO QD on days 1-3 and low-dose vorinostat PO QD on days 8-10. After 5 days, patients receive vorinostat and paclitaxel as in Arm V.

Group II: Arm V (low- and mid-dose vorinostat and paclitaxel)Experimental Treatment4 Interventions

Patients receive low-dose vorinostat PO QD on days 1-3 and mid-dose vorinostat PO QD on days 8-10 (course 0). After 5 days, patients receive mid-dose vorinostat PO QD on days 1-3 and paclitaxel IV over 3 hours on day 3.

Group III: Arm IV (low- and high-dose vorinostat and carboplatin)Experimental Treatment4 Interventions

Patients receive low-dose vorinostat and high-dose vorinostat as in Arm III. After 5 days, patients receive vorinostat and carboplatin as in Arm II.

Group IV: Arm III (low- and high-dose vorinostat and carboplatin)Experimental Treatment4 Interventions

Patients receive low-dose vorinostat PO QD on days 1-3 and high-dose vorinostat PO QD on days 8-10 (course 0). After 5 days, patients receive vorinostat and carboplatin as in Arm I.

Group V: Arm II (high- and low-dose vorinostat and carboplatin)Experimental Treatment4 Interventions

Patients receive high-dose vorinostat and low-dose vorinostat as in Arm I. After 5 days, patients receive lower-dose vorinostat PO QD on days 1-3 and carboplatin IV over 30 minutes on day 3.

Group VI: Arm I (high- and low-dose vorinostat and carboplatin)Experimental Treatment4 Interventions

Patients receive high-dose vorinostat PO QD on days 1-3 and low-dose vorinostat PO QD on days 8-10 (course 0). After 5 days, patients receive high-dose vorinostat PO QD on days 1-3 and carboplatin IV over 30 minutes on day 3 of all subsequent courses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5450