Clinical trial · Interventional
S0423 Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma
Phase II Trial of Pemetrexed for Advanced Chondrosarcomas
NCT00107419CI-TRIAL-00006068completedPhase 2ClinicalTrials.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)
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent and unresectable or metastatic chondrosarcoma.
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 | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pemetrexed
- description
- pemetrexed
- interventionNames
- Drug: pemetrexed disodium
Primary outcomes (1)
- measure
- Response rate as measured by RECIST criteria
- timeFrame
- every 9 weeks during treatment
- description
- x-rays or scans
Secondary outcomes (2)
- measure
- Toxicity as measured by CTC v 3.0
- timeFrame
- every 3 weeks during treatment
- description
- side-effect evaluation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed chondrosarcoma * Histologic grade G2 or G3 * Recurrent and unresectable OR metastatic disease * Measurable disease by x-ray, scan, ultrasound, or physical examination * No known CNS metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin \< 1.5 times upper limit of normal (ULN) * SGOT or SGPT \< 2.5 times ULN (5 times ULN if liver metastases are present) Renal * Creatinine clearance \> 45 mL/min Other * Not pregnant or nursing * Fertile patients must use effective contraception * Able to swallow oral medication * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * More than 28 days since prior biologic therapy for this malignancy Chemotherapy * More than 28 days since prior chemotherapy for this malignancy Endocrine therapy * Not specified Radiotherapy * At least 60 days since prior radiotherapy to the target lesion\* * No concurrent radiotherapy NOTE: \*Target lesion must have demonstrated disease progression after completion of therapy Surgery * At least 21 days since prior surgery and recovered Other * More than 28 days since prior investigational drugs for this malignancy * At least 60 days since prior embolization or radiofrequency ablation to the target lesion\* * No more than 2 prior treatment regimens for this malignancy * No concurrent antiretroviral therapy for HIV-positive patients NOTE: \*Target lesion must have demonstrated disease progression after completion of therapy
References
Publications (0)
Data not yet available
No reference posted for this study.