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Alkylating agents

Pemetrexed + Cisplatin +/- Cediranib for Mesothelioma

Q: How many sites are offering access to this experiment?

<p>Highlands <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> Group - Rogers in Rogers, <a href="https://www.withpower.com/clinical-trials/arkansas">Arkansas</a>, Kaiser Permanente San Leandro in San Leandro, <a href="https://www.withpower.com/clinical-trials/california">California</a> and Prisma Health <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Institute - Eastside in Greenville, <a href="https://www.withpower.com/clinical-trials/south-carolina">South carolina</a> are amongst the many medical centres hosting this trial.</p>

Phase 1 & 2

Waitlist Available

Led By Anne S Tsao

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

Patient must have Zubrod performance status 0-2

Calculated creatinine clearance >= 60 mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.best response is documented for as long as the patient remains on protocol treatment.

Awards & highlights

Study Summary

This trial is studying the side effects and best dose of cediranib maleate when given with pemetrexed disodium and cisplatin to treat patients with malignant pleural mesothelioma.

Who is the study for?

This trial is for patients with malignant pleural mesothelioma who haven't had systemic therapy for it. They can have had previous neoadjuvant or adjuvant treatment if it was over 6 months ago and didn't include cediranib. Participants need proper organ function, no plans for surgery, not pregnant or nursing, and must use effective contraception.Check my eligibility

What is being tested?

The study tests the effectiveness of combining pemetrexed disodium and cisplatin with cediranib maleate versus without it in treating mesothelioma. It aims to find the best dose of cediranib that's safe when used with chemotherapy drugs which stop tumor growth by killing cells or stopping their division/spread.See study design

What are the potential side effects?

Potential side effects may include issues related to blocking enzymes needed for cell growth and blood flow to tumors, such as fatigue, digestive problems, blood disorders, possible heart rhythm changes (QTc prolongation), risk of significant bleeding (hemoptysis), among others.

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 and am up and about more than 50% of my waking hours.

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My kidneys are functioning well.

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I am not planning to undergo any other cancer treatments while on this trial.

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I have been diagnosed with mesothelioma and surgery is not planned.

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My recent ECG shows normal heart rhythm and I don't take heart-risky drugs.

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I am not on medications like vancomycin that could affect my kidney function.

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I do not have HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.best response is documented for as long as the patient remains on protocol treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.best response is documented for as long as the patient remains on protocol treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.best response is documented for as long as the patient remains on protocol treatment. for reporting.

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 of Cediranib in Combination With Cisplatin and Pemetrexed (Phase I)

Progression-free Survival (Phase II)

Secondary outcome measures

(Phase I) Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

(Phase II) Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Disease Control Rate by Modified RECIST (Phase II)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (pemetrexed disodium, cisplatin, cediranib maleate))Experimental Treatment4 Interventions

Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (pemetrexed disodium, cisplatin, placebo)Active Control4 Interventions

Patients receive pemetrexed disodium and cisplatin as in arm I and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pemetrexed Disodium

2015

Completed Phase 2

~280

Cediranib Maleate

2010

Completed Phase 2

~660

Cisplatin

2013

Completed Phase 3

~1940

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,036 Total Patients Enrolled

93 Trials studying Mesothelioma

8,538 Patients Enrolled for Mesothelioma

Anne S TsaoPrincipal InvestigatorSWOG Cancer Research Network

6 Previous Clinical Trials

243 Total Patients Enrolled

2 Trials studying Mesothelioma

84 Patients Enrolled for Mesothelioma

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01064648 — Phase 1 & 2

Mesothelioma Research Study Groups: Arm I (pemetrexed disodium, cisplatin, cediranib maleate)), Arm II (pemetrexed disodium, cisplatin, placebo)

Mesothelioma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT01064648 — Phase 1 & 2

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01064648 — Phase 1 & 2

Frequently Asked Questions

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

Are there vacancies available for this research program?

"Per the information that is available on clinicaltrials.gov, this trial is currently not recruiting patients. It was initially posted in March 2010 and last updated in September 2022. However, there are numerous other trials seeking volunteers at present, with a total of 2467 listings as of now."

Answered by AI

How many sites are offering access to this experiment?

"Highlands Oncology Group - Rogers in Rogers, Arkansas, Kaiser Permanente San Leandro in San Leandro, California and Prisma Health Cancer Institute - Eastside in Greenville, South carolina are amongst the many medical centres hosting this trial."

Answered by AI

What purpose does this experiment seek to accomplish?

"The primary outcome of this clinical trial, evaluated over an extended period up to five years from registration, will be the Maximum Tolerated Dose of Cediranib in Combination With Cisplatin and Pemetrexed (Phase I). Secondary outcomes include Response Rate by Modified RECIST (Phase II), Disease Control Rate by Modified RECIST (Phase II) and Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs( Phase I). All target measurable lesions must adhere to standardized criteria as outlined."

Answered by AI

What is the maximum cap of participants for this clinical exploration?

"Unfortunately, this study is not accepting new participants at present. It was first posted on March 15th 2010 and most recently modified September 20th 2022. For those seeking other trials for mesothelioma, 1614 studies are currently enrolling patients, while 853 scientific investigations are recruiting individuals to test the effects of Cediranib Maleate."

Answered by AI

What prior examinations have been conducted concerning Cediranib Maleate?

"Cediranib Maleate was initially trialled in 1997 by City of Hope Comprehensive Cancer Center, and since then there has been a total of 1746 concluded clinical trials. Currently 853 live studies are ongoing, with many taking place at Rogers, Arkansas."

Answered by AI