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Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy (PACT-18)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01339754
First Posted: April 21, 2011
Last Update Posted: August 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michele Reni, IRCCS San Raffaele
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer Drug: trabectedin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial

Resource links provided by NLM:


Further study details as provided by Michele Reni, IRCCS San Raffaele:

Primary Outcome Measures:
  • Progression-free survival (PFS) rate at 6 months [ Time Frame: every 9 weeks ]
    CT scan


Secondary Outcome Measures:
  • Safety profile [ Time Frame: every 3 weeks ]
    outpatient visit, laboratory findings

  • Response rate and response duration [ Time Frame: every 2 months ]
    CT scan

  • Overall survival [ Time Frame: every 3 weeks during therapy, every 2-3 months thereafter ]
    outpatient visit, phone interview

  • PFS rate at 9 and 18 weeks [ Time Frame: every 9 weeks ]
    CT scan

  • Identify biomarkers predictive for resistance or sensitivity to trabectedin [ Time Frame: at trial start ]
    tissue, blood, serum collection

  • Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity [ Time Frame: based on a pre-definid sample collection schedule ]
    blood samples


Enrollment: 25
Study Start Date: February 2011
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: YONDELIS
Drug: trabectedin
1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression
Other Name: ET 743

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339754


Locations
Italy
Istituto Scientifico H. San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Michele Reni, MD Istituto Scientifico H. San Raffaele
  More Information

Responsible Party: Michele Reni, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01339754     History of Changes
Other Study ID Numbers: CDR0000698981
PACT-18 ( Other Identifier: IRCCS San Raffaele )
2010-024287-17 ( EudraCT Number )
First Submitted: April 20, 2011
First Posted: April 21, 2011
Last Update Posted: August 11, 2014
Last Verified: August 2014

Keywords provided by Michele Reni, IRCCS San Raffaele:
recurrent pancreatic cancer
stage IV pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents