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

Phase 2
18 Years
75 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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


- 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


- See Disease Characteristics

- No prior second-line chemotherapy

- No other concurrent chemotherapy or target therapy

- No concurrent treatment with other experimental drugs

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) rate at 6 months

Outcome Description:

CT scan

Outcome Time Frame:

every 9 weeks

Safety Issue:


Principal Investigator

Michele Reni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Scientifico H. San Raffaele


Italy: Ministry of Health

Study ID:




Start Date:

February 2011

Completion Date:

December 2012

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • adenocarcinoma of the pancreas
  • Adenocarcinoma
  • Pancreatic Neoplasms