Pancreatic Cancer
Conditions
Keywords
recurrent pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas
Brief summary
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
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.
Interventions
DRUGtrabectedin
1.3 mg/mq as a 3 hour continuous infusion every three weeks
Sponsors
IRCCS San Raffaele
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) rate at 6 months | every 9 weeks | CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate and response duration | every 2 months | CT scan |
| Overall survival | every 3 weeks during therapy, every 2-3 months thereafter | outpatient visit, phone interview |
| Safety profile | every 3 weeks | outpatient visit, laboratory findings |
| Identify biomarkers predictive for resistance or sensitivity to trabectedin | at trial start | tissue, blood, serum collection |
| Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity | based on a pre-definid sample collection schedule | blood samples |
| PFS rate at 9 and 18 weeks | every 9 weeks | CT scan |
Countries
Italy
Outcome results
None listed