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Alkylating agents

Pemetrexed + Cisplatin +/- Cediranib for Mesothelioma

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.

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.

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.

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

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

Primary study objectives

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

Progression-free Survival (Phase II)

Secondary study objectives

(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

~450

Cediranib Maleate

2010

Completed Phase 2

~660