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

Study Overview

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

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 * 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.

Pancreatic Cancer

DRUG: trabectedin
DRUG: trabectedin

CDR0000698981
PACT-18 (OTHER Identifier) (OTHER: IRCCS San Raffaele)
2010-024287-17 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-04-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-08-08
First Submitted that Met QC Criteria 2011-04-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-08-11
First Posted (ESTIMATED) 2011-04-21	Results First Posted N/A	Last Verified 2014-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: trabectedin 1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression	DRUG: trabectedin 1.3 mg/mq as a 3 hour continuous infusion every three weeks DRUG: trabectedin 1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: trabectedin

1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression

DRUG: trabectedin

1.3 mg/mq as a 3 hour continuous infusion every three weeks

DRUG: trabectedin

1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression

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

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Michele Reni, MD, Istituto Scientifico H. San Raffaele

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record