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| ID | Type | Description | Link |
|---|---|---|---|
| PACT-18 | Other Identifier | IRCCS San Raffaele | |
| 2010-024287-17 | EudraCT Number |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Blood samples and tumor tissue are analyzed for identifying biological markers predictive for resistance to treatment and pharmacogenomic and pharmacokinetic profiling on anti-tumor activity in translational research studies.
After completion of study treatment, patients are followed up periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trabectedin | Experimental | 1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trabectedin | Drug | 1.3 mg/mq as a 3 hour continuous infusion every three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) rate at 6 months | CT scan | every 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile | outpatient visit, laboratory findings | every 3 weeks |
| Response rate and response duration | CT scan | every 2 months |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the pancreas
Metastatic disease progressed after 1 prior gemcitabine-contained chemotherapy
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Michele Reni, MD | Istituto Scientifico H. San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Scientifico H. San Raffaele | Milan | 20132 | Italy |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000077606 | Trabectedin |
| ID | Term |
|---|---|
| D004149 | Dioxoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| trabectedin | Drug | 1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression |
|
|
| Overall survival | outpatient visit, phone interview | every 3 weeks during therapy, every 2-3 months thereafter |
| PFS rate at 9 and 18 weeks | CT scan | every 9 weeks |
| Identify biomarkers predictive for resistance or sensitivity to trabectedin | tissue, blood, serum collection | at trial start |
| Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity | blood samples | based on a pre-definid sample collection schedule |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007546 |
| Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |