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Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin

NCT00611962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2008-02-11

No results posted yet for this study

Summary

To evaluate the efficacy of the oxaliplatin-paclitaxel combination i.e. evaluation of tumor response rate using World Health Organization/Union Internationale Contre le Cancer (WHO/UICC) and Indianapolis tumor marker (human chorionic gonadotropin \[hCG\], alpha fetoprotein \[AFP\]) criteria in metastatic germ cell cancer patients

Conditions

  • Neoplasms, Germ Cell and Embryonal

Interventions

DRUG

Oxaliplatin, Paclitaxel

Oxaliplatin was provided in clear glass vials sealed with a rubber stopper and an aluminum seal with a flip-off cover. Each vial contained 50 or 100 mg of active ingredient with 450 or 900 mg, respectively, of lactose monohydrate as excipient Paclitaxel was supplied as single dose vials of 30 mg/5 mL or 100 mg/17 mL.

Sponsors & Collaborators

Principal Investigators

  • Nathalie Billon · Sanofi

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
2000-12-31
Completion
2004-03-31

Countries

  • France

Study Locations

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Entities

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 NCT00611962 on ClinicalTrials.gov