Clinical trial NCT01339754: Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy
Official title: Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer
stage IV pancreatic cancer
adenocarcinoma of the pancreas
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2011-04-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Progression-free survival (PFS) rate at 6 months
timeFrame: every 9 weeks
Secondary outcomes:
measure: Safety profile
timeFrame: every 3 weeks
measure: Response rate and response duration
timeFrame: every 2 months
measure: Overall survival
timeFrame: every 3 weeks during therapy, every 2-3 months thereafter
measure: PFS rate at 9 and 18 weeks
timeFrame: every 9 weeks
measure: Identify biomarkers predictive for resistance or sensitivity to trabectedin
timeFrame: at trial start
measure: Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity
timeFrame: based on a pre-definid sample collection schedule
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Scientifico H. San Raffaele
Study officials:
affiliation: Istituto Scientifico H. San Raffaele
name: Michele Reni, MD
role: PRINCIPAL_INVESTIGATOR
References: