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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Peak concentrations (Cmax) of vorinostat at 400, 1200, and 1600 mg
Secondary outcome measures
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
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
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Vorinostat
2014
Completed Phase 3
~1600
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,343 Total Patients Enrolled
Michael L MaitlandPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is advanced, cannot be surgically removed, and has no better treatment options.I am allergic to medications similar to paclitaxel, vorinostat, or carboplatin.I cannot swallow pills.I am not pregnant or breastfeeding, and if capable of becoming pregnant, I agree to use contraception during the study.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.It's been over 4 weeks since my last cancer treatment, or 6 weeks if it included BCNU or mitomycin C.My kidney function is normal or nearly normal.I am not HIV-positive or not on antiretroviral therapy.I don't have untreated or worsening brain metastases and am not on steroids or certain seizure medications.I am fully active or restricted in physically strenuous activity but can do light work.I have used valproic acid before.
Research Study Groups:
This trial has the following groups:- Group 1: Arm VI (mid- and low-dose vorinostat and paclitaxel)
- Group 2: Arm V (low- and mid-dose vorinostat and paclitaxel)
- Group 3: Arm III (low- and high-dose vorinostat and carboplatin)
- Group 4: Arm II (high- and low-dose vorinostat and carboplatin)
- Group 5: Arm IV (low- and high-dose vorinostat and carboplatin)
- Group 6: Arm I (high- and low-dose vorinostat and carboplatin)
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.
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