Clinical trial · Interventional
Alimta Plus Gemcitabine for Advanced Sarcoma
Alimta Plus Gemcitabine as Chemotherapy for Patients With Advanced Sarcoma: A Phase II Clinical
NCT00860015CI-TRIAL-00046787completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In patients with unresectable soft tissue sarcoma, what is the response rate if treated with Alimta and gemcitabine?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma, Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alimta | Drug | Pemetrexed | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alimta/Gemcitabine
- description
- IV administration of drugs for 14 days for up to 4 cycles
- interventionNames
- Drug: Alimta
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Tumor Best Response Rate
- timeFrame
- Two months
- description
- The best response rate will include patients with both Complete Response and Partial Response after 2 months of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven soft tissue sarcoma (except the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's Sarcoma, mesotheliomas). * Age ≥ 18 years * Recurrent or progressive disease defined as an increase in size of any existing tumor mass, or the development of new tumor mass or masses, which is not amenable to definitive surgical therapy. * Patients may have had another cancer but there must be convincing clinical evidence that the sarcoma is the disease requiring therapeutic intervention. (i.e. Several sarcoma patients have had had a prior cancer \[Hodgkin's disease or breast cancer\] treated years previously and then developed a clinically active sarcoma.) * Patients may have received no prior chemotherapy, or may have failed 0-2 prior cytotoxic regimens. * Measurable disease defined as lesions that can be measured in at least one dimension by physical examination or by means of medical imaging techniques. Ascites and pleural effusions will not be considered measurable disease. * Karnofsky performance status of greater than or equal to 60%. * At least 3 weeks since prior chemotherapy or at least 6 weeks since prior radiation therapy. Exclusion Criteria: * Soft tissue sarcomas with the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's sarcoma, mesotheliomas. * Active or uncontrolled infection * Prior treatment with gemcitabine or Alimta * Pregnant or lactating women * Uncontrolled central nervous system metastases * Inability to stop treatment with NSAIDs
References
Publications (0)
Data not yet available
No reference posted for this study.