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ASA404 in Combination With Carboplatin/Paclitaxel/Cetuximab in Treating Patients With Refractory Solid Tumors

NCT01031212 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-05-13

No results posted yet for this study

Summary

This phase I trial is studying the side effects and best dose of an investigational drug called DMXAA (5-6-dimethylxanthenone-4-acetic acid) or ASA404 when given together with carboplatin, paclitaxel and cetuximab to treat patients with refractory solid tumors.

Conditions

Interventions

DRUG

ASA404

Administered intravenously over 20 minutes weekly after chemotherapy

DRUG

Cetuximab

Administered at 400mg/m2 over 120 minutes on day -7 and then 250mg/m2 over 60 minutes weekly thereafter

DRUG

Carboplatin

Administered at fixed dose of AUC 6 intravenously on day 1 of each 3-week cycle

DRUG

Paclitaxel

Administered over 3 hours at a fixed dose of 175mg/m2 intravenously on day 1 of each 3-week cycle

Sponsors & Collaborators

Principal Investigators

  • Sarita Dubey, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01031212 on ClinicalTrials.gov