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Abraxane and Alimta in Advanced Solid Tumors

NCT00470548 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-01-10

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized nanoparticle formulation together with pemetrexed may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with pemetrexed and to see how well they work in treating patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors.

Conditions

Interventions

DRUG

Abraxane

ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)

DRUG

Alimta

Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Eli Lilly and Company

    collaborator INDUSTRY

  • University of California, Davis

    lead OTHER

Principal Investigators

  • David R. Gandara, MD · University of California, Davis

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2014-10-31
Completion
2014-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00470548 on ClinicalTrials.gov