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Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer

NCT01548144 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2021-09-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Crizotinib (Xalkori)

Starting dose for Crizotinib - Groups A, B, C: 250 mg by mouth every other day, 1 or 2 times a day on Day 1 of a 21 day cycle. Participant told how often to take this drug. Expansion Groups Starting Dose: MTD from Phase 1.

DRUG

Pazopanib

Starting Dose for Pazopanib - Groups A, C, D: 200 mg by mouth daily in a 21 day cycle. Expansion Groups Starting Dose: MTD from Phase 1.

DRUG

Pemetrexed

Starting dose for Pemetrexed - Groups B + C: 200 mg/m2 by vein on Day 1 of a 21 day cycle. Expansion Groups Starting Dose: MTD from Phase 1. Starting dose for Pemetrexed Group D: 400 mg/m2 by vein every 3 weeks on Day 1 of a 21 day cycle. Expansion Group Starting Dose: MTD from Phase 1.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Sarina Piha-Paul, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2021-08-26
Completion
2021-08-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01548144 on ClinicalTrials.gov