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Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy

NCT00807261 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2008-12-12

No results posted yet for this study

Summary

To determine the activity of weekly Docetaxel and Gemcitabine in patients with advanced soft tissue sarcoma previously treated with anthracycline and/or ifosfamide

1. Primary endpoint: response rate
2. Secondary endpoint: progress-free survival, overall survival, safety

Conditions

  • Sarcoma

Interventions

DRUG

Gemcitabine and Docetaxel

Drug and schedule * Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min (D1, D8) * Docetaxel 35 mg/m2 IV (D1, D8) .. every 21 days Dose modification * Treatment should be delayed if the ANC\<1,500/ mm3, or if the platelet count \<75,000/mm3 on the first day of the next cycle. * Gemcitabine \& docetaxel are omitted on day 8, when ANC is less than 1000/mm3 or platelet count is less than 50,000/mm3; it is reduced by 25% if the ANC is between 1,000 and 1,500/mm3 or the platelet count is between 50,000 and 75,000/mm3 Study design Treatment should consist of at least 2 cycles unless rapid disease progression or unacceptable toxicities occur after one cycle of chemotherapy. Patients with response or no change will receive 2 additional cycles.

Sponsors & Collaborators

  • Severance Hospital

    collaborator OTHER

  • Korea University Anam Hospital

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Jin-hee Ahn · AIDS Malignancy Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-09-30
Completion
2010-09-30

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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 NCT00807261 on ClinicalTrials.gov