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Gemox as First and Second Line Therapy in Unknown Primary Cancer

NCT00353145 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2012-08-02

No results posted yet for this study

Summary

Primary objectives:

1. To determine the overall tumor response rate with oxaliplatin in combination with gemcitabine (GEMOX) as first line and second line therapy in unknown primary cancer (UPC).
2. To determine the tolerability (toxicity) of this regimen in this patient population.

Secondary objectives:

1. To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.
2. To determine the impact of this combination on quality of life (QOL) in this patient population.

Conditions

  • Unknown Primary Neoplasms

Interventions

DRUG

Gemcitabine (Gemox)

1000 mg/m\^2, infused at 10 mg/m\^2/min on Day 1 repeated every 14 days (one cycle).

DRUG

Oxaliplatin

100 mg/m\^2 by vein infused on Day 2 over two hours, repeated every 14 days (one cycle).

BEHAVIORAL

Questionnaire

Quality of Life Surveys

Sponsors & Collaborators

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Gauri R. Varadhachary, MD · M.D. Anderson Cancer Center

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
2004-02-29
Primary Completion
2007-03-31
Completion
2010-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00353145 on ClinicalTrials.gov