CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Alimta +1 moredrug
Likely dose
Alimta 500 mg/m² IV over 10 minutes plus Gemcitabine 1000 mg/m² IV over 90 minutesAI-extracted
Key inclusion· 5
  • ✓Histologically confirmed soft tissue sarcoma (excluding GIST, Kaposi's sarcoma, mesotheliomas)
  • ✓Age ≥18 years
  • ✓Recurrent or progressive disease not amenable to definitive surgical therapy
  • ✓Measurable disease by physical exam or imaging
Key exclusion· 5
  • ✕Specific sarcoma histologies: GIST, Kaposi's sarcoma, mesotheliomas
  • ✕Prior treatment with gemcitabine or Alimta
  • ✕Active or uncontrolled infection
  • ✕Uncontrolled CNS metastases

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

Search/NCT00860015
NCT00860015Phase 2Completed
CompareCT.gov

Alimta Plus Gemcitabine as Chemotherapy for Patients With Advanced Sarcoma: A Phase II Clinical

Columbia University·interventional·Posted Mar 11, 2009·Updated Aug 25, 2020

In Brief

A Phase 2 clinical trial evaluating Alimta and Gemcitabine for Sarcoma, Soft Tissue. Completed, enrolled 12 participants across 1 site.

Detailed Summary

In patients with unresectable soft tissue sarcoma, what is the response rate if treated with Alimta and gemcitabine?

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 11, 2009
Enrollment StartAug 1, 2005
Primary CompletionAug 1, 2009
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.3 years ago

Interventions

Alimtadrug

500 mg/m2 via IV over 10 minutes A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer.

Gemcitabinedrug

1000 mg/m2 via IV over 90 minutes A nucleoside analog used as chemotherapy.