Viewing Study NCT01548144



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Last Modification Date: 2024-10-26 @ 10:48 AM
Study NCT ID: NCT01548144
Status: TERMINATED
Last Update Posted: 2021-09-13
First Post: 2012-03-05

Brief Title: Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer
Sponsor: MD Anderson Cancer Center
Organization: MD Anderson Cancer Center

Study Overview

Official Title: A Two Steps Phase I Trial of Pazopanib or Pemetrexed in Combination With Crizotinib Followed by the Triplet Crizotinib Plus Pazopanib Plus Pemetrexed in Patients With Advanced Malignancies
Status: TERMINATED
Status Verified Date: 2021-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: PI request
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this clinical research study is to find the highest tolerable dose of the combination of Xalkori crizotinib either with Votrient pazopanib or Alimta pemetrexed or of the combination of 3 study drugs that can be given to patients with advanced cancer The safety of these drug combinations will also be studied

Crizotinib is designed to block a protein called ALK which is involved in cancer cell growth and survival

Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth This may prevent or slow the growth of cancer cells

Pemetrexed is designed to block proteins that may cause tumors to grow

This is an investigational study Crizotinib is FDA approved and commercially available for the treatment of locally advanced or metastatic non-small cell lung cancer Pazopanib is FDA approved and commercially available for treatment of advanced renal cell carcinoma Pemetrexed is FDA approved and commercially available for the treatment of non-small cell lung cancer

The combination of crizotinib with pazopanib crizotinib with pemetrexed pazopanib with pemetrexed and giving all 3 drugs together to patients with advanced cancer is investigational

Up to 364 patients will take part in this study All will be enrolled at MD Anderson
Detailed Description: Study groups

Dose escalation

If you are found to be eligible to take part in this study your doctor will decide if you will receive one of the following drug combinations

If you are in Group A you will receive crizotinib and pazopanib
If you are in Group B you will receive crizotinib and pemetrexed
If you are in Group C you will receive pazopanib and pemetrexed
If you are in Group D you will receive crizotinib pazopanib and pemetrexed

Once it is decided which combination you will receive you will be assigned to a dose level based on when you join the study

Up to 8 dose levels of crizotinib with pazopanib will be tested Up to 6 dose levels of crizotinib with pemetrexed will be tested Up to 6 dose levels of pazopanib with pemetrexed will be tested Up to 8 dose levels of pazopanib with pemetrexed and crizotinib will be tested Up to 6 participants will be enrolled at each dose level

The first group of participants will receive the lowest dose level Each new group will receive a higher dose than the group before it if no intolerable side effects were seen This will continue until the highest tolerable dose combination is found

Dose expansion

Once the highest tolerable dose of each study drug combination is found up to 14 more participants may be enrolled to further study the safety of each combination of drugs at that dose

Study Drug Administration

Each study cycle is 21 days Drugs should be taken andor administered simultaneously On days of pharmacokinetic testing if you agree you should take the drugs at least 1 hour before or 2 hours after a meal

If you are taking crizotinib you will take it by mouth at the same time every day consistently either with or without food It should be swallowed whole with a glass of water You will take the drug every other day 1 or 2 times a day You will be told how often to take this drug

If you are taking pazopanib you will take it by mouth at the same time every day with a glass of water You should take it at least 1 hour before or 2 hours after a meal

If you receive pemetrexed

You will receive it by vein on Day 1 of each cycle over about 10 minutes
The day before your first dose of pemetrexed you will start taking folic acid to help lower the risk of side effects Although the study drug is designed to prevent the body from making folic acid that could help cancer grow and spread some folic acid is needed to prevent side effects in non-cancerous tissue You will take folic acid by mouth 1 time every day until at least 30 days after you received the last dose of pemetrexed
The day before your first dose of pemetrexed you will receive a vitamin B12 injection You will receive an injection of Vitamin B12 about every 9 weeks after that Vitamin B12 is given to help reduce the risks of side effects
You will take dexamethasone by mouth 2 times a day on the day before the day of and the day after you receive pemetrexed

Study Visits

At every study visit you will be asked about any other drugs or herbal supplements you are taking and about any side effects you may have

During Cycles 1 and 2 you will have weekly blood about 1 tablespoon collected for routine tests

During Week 1 of Cycles 2 and beyond

Your medical history will be recorded including any cancer symptoms
You will have a physical exam including measurement of your weight and vital signs
Your performance status will be recorded
Blood about 1 tablespoon and urine will be collected for routine tests
If your doctor thinks it is needed you will have an ECG to check your heart function

Every 6 weeks or earlier if needed blood about 1 tablespoon will be drawn for tumor marker testing

After about 6 weeks and then every 2-3 cycles after that you will have a CT scan x-ray MRI scan andor PET scan to check the status of the disease It may be done more often if your study doctor thinks it is needed

If you are able to become pregnant you will have a blood about 1 teaspoon or urine pregnancy test every 2 cycles or at any time the study doctor thinks it is needed

Length of Study Participation

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest You will no longer be able to take the study drugs if the disease gets worse if intolerable side effects occur or if you are unable to follow study directions

Your participation on the study will be over once you have completed the end-of-dosing andor follow-up visits

End-of-Dosing Visit

Within 30 days after your last dose of study drugs you will have an end-of-study visit If you are having side effects at the time of this visit you may have follow-up for a longer period of time At this visit the following tests or procedures may be performed

Your medical history will be recorded including any cancer symptoms
You will be asked if you have had any side effects
You will have a physical exam including measurement of your weight and vital signs
Your performance status will be recorded
Blood about 1 tablespoon and urine will be collected for routine tests
Blood about 1 tablespoon will be drawn for tumor marker testing
If the doctor thinks it is needed you will have an x-ray CT scan MRI scan andor PETCT scan to check the status of the disease
If your doctor thinks it is needed you will have an ECG to check your heart function

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NCI-2012-00324 REGISTRY NCI CTRP None