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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 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.

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
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

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
13,603 Previous Clinical Trials
40,913,255 Total Patients Enrolled
Michael L MaitlandPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01281176 — Phase 1
Solid Tumors Research Study Groups: Arm VI (mid- and low-dose vorinostat and paclitaxel), Arm V (low- and mid-dose vorinostat and paclitaxel), Arm III (low- and high-dose vorinostat and carboplatin), Arm II (high- and low-dose vorinostat and carboplatin), Arm IV (low- and high-dose vorinostat and carboplatin), Arm I (high- and low-dose vorinostat and carboplatin)
Solid Tumors Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT01281176 — Phase 1
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01281176 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been accepted into this trial?

"At this point in time, no new patients are being accepted for this trial. It was originally published on February 9th 2011 and last updated June 28th 2022. However, if you search elsewhere there are currently 5 active studies seeking participants with adult solid neoplasms and 1203 pharmacological trials that have open enrolment periods."

Answered by AI

Has the Pharmacological Study been greenlit by the FDA?

"Data associated with the safety and efficacy of this pharmacological study is limited, so it was rated a 1 on our team's scale."

Answered by AI

What findings have been made in other research studies pertaining to Pharmacological Study?

"Presently, 1203 clinical trials are being conducted to investigate Pharmacological Study and 334 of those studies are in Phase 3. While Shanghai is the epicenter for these tests, a total of 67318 sites globally have been designated as testing grounds for this research."

Answered by AI

What are the predominant indications for Pharmacological Study?

"Pharmacological Study is suitable for alleviating the symptoms of malignant peritoneal neoplasm, advanced endometrial cancer, and palliative therapy."

Answered by AI

Is this investigation actively seeking participants?

"This trial has closed its recruitment period and is no longer seeking participants. Initially posted on February 9th 2011, the study was last updated June 28th 2022. For those searching for active studies, there are currently five trials recruiting patients with solid neoplasm; in addition, 1203 pharmacological studies are actively looking for volunteers to join their investigations."

Answered by AI
~1 spots leftby Mar 2025