MedTrace Logo

Capecitabine, Carboplatin and Weekly Paclitaxel for Patients With Solid Tumors and Adenocarcinoma of Unknown Primary

NCT00201734 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2016-09-23

Study results available
· View outcomes & findings →

Summary

This study will determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks with carboplatin.

Conditions

  • Tumors
  • Unknown Primary Tumors
  • Adenocarcinoma

Interventions

DRUG

Capecitabine

Level 1: 500 mg/m2 orally twice daily Days 8 - 21 of each cycle. Level 2: 750 mg/m2 orally twice daily Days 8 - 21 of each cycle. Level 3 - 5: 1000mg/m2 orally twice daily Days 8 - 21 of each cycle.

DRUG

Carboplatin

Levels 1-5: AUC of 6 every 4 weeks.

DRUG

Paclitaxel

Level 1-3: 60 mg/m2/week. Level 4: 80 mg/m2/week. Level 5: 100 mg/m2/week.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Tony Bekaii-Saab · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2007-11-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00201734 on ClinicalTrials.gov