Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary To assess the therapeutic activity of trabectedin, in terms of progression-free survival (PFS) rate at 6 months, in patients with metastatic pancreatic adenocarcinoma progressed after gemcitabine-containing first-line chemotherapy. Secondary To assess the safety profile of this drug. To assess the response rate and response duration. To assess the overall survival of these patients. To assess the PFS rate at 9 and 18 weeks. To perform blood, plasma, and tumor tissue sampling for biological studies, in order to identify biomarkers predictive for resistance or sensitivity to trabectedin, and to characterize the impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity in translational research studies. 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.

Official Title
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Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: trabectedin
* Drug: trabectedin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trabectedin<br>1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression | Drug: trabectedin<br>* 1.3 mg/mq as a 3 hour continuous infusion every three weeks<br>* Other names: YONDELIS;Drug: trabectedin<br>* 1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression<br>* Other names: ET 743;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) rate at 6 months | CT scan | every 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile | outpatient visit, laboratory findings | every 3 weeks | 
| Response rate and response duration | CT scan | every 2 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas