Clinical trial · Interventional
Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy
Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial
NCT01339754CI-TRIAL-00015357PACT-18completedPhase 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: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with metastatic pancreatic cancer after first-line chemotherapy.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trabectedin | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- trabectedin
- description
- 1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression
- interventionNames
- Drug: trabectedin
Primary outcomes (1)
- measure
- Progression-free survival (PFS) rate at 6 months
- timeFrame
- every 9 weeks
- description
- CT scan
Secondary outcomes (6)
- measure
- Safety profile
- timeFrame
- every 3 weeks
- description
- outpatient visit, laboratory findings
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas * Metastatic disease progressed after 1 prior gemcitabine-contained chemotherapy * May be given with neoadjuvant, adjuvant, or palliative therapy * Measurable disease according to RECIST criteria * No symptomatic brain metastasis PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Bone marrow, liver, and kidney function normal * Not pregnant or nursing * Fertile patients must use effective contraception * No severe comorbidities, including any of the following: * Cardiac disease * History of psychiatric disability * No other prior or concurrent malignancy except surgically cured carcinoma in-situ of the cervix, basal cell or squamous cell carcinoma of the skin, and other neoplasms without evidence of disease for ≥ 5 years * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior second-line chemotherapy * No other concurrent chemotherapy or target therapy * No concurrent treatment with other experimental drugs
References
Publications (0)
Data not yet available
No reference posted for this study.