CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
ifosfamide and doxorubicin vs gemcitabine and docetaxeldrug
Likely dose
Arm 1: Doxorubicin and ifosfamide with mesna delivered over 3 days at 21-day intervals, plus filgrastim days 4-10 or peg-filgrastim day 4. Arm 2: Gemcitabine and docetaxel with filgrastim.AI-extracted
Key inclusion· 5
  • ✓Soft tissue sarcoma diagnosis
  • ✓Intermediate or high histologic grade
  • ✓Tumor size greater than 5 cm
  • ✓No evidence of metastasis
Key exclusion· 5
  • ✕Prior chemotherapy
  • ✕Specific excluded histologic types: clear cell, alveolar soft part, Ewing's rhabdosarcoma, undifferentiated small cell, or Kaposi's sarcoma
  • ✕Active unstable angina pectoris
  • ✕Concurrent therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00189137
NCT00189137Phase 2Completed
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Phase II Evaluation of Ifosfamide Plus Doxorubicin & Filgrastim Versus Gemcitabine Plus Docetaxel & Filgrastim in the Treatment of Localized Poor Prognosis Soft Tissue Sarcoma

University of Michigan Rogel Cancer Center·interventional·Posted Sep 16, 2005·Updated Dec 7, 2015

In Brief

A Phase 2 clinical trial evaluating ifosfamide and doxorubicin vs gemcitabine and docetaxel for Sarcoma, Soft Tissue. Completed, enrolled 84 participants across 1 site.

Detailed Summary

The purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma, Soft Tissue
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartAug 1, 2004
Primary CompletionNov 1, 2012
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 20.8 years ago

Interventions

ifosfamide and doxorubicin vs gemcitabine and docetaxeldrug

Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor. Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4. All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.