Back to resultsTrabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy (PACT-18)
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
trabectedin
trabectedin
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas
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
Sites / Locations
- Istituto Scientifico H. San Raffaele
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
trabectedin
Arm Description
1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression
Outcomes
Primary Outcome Measures
Progression-free survival (PFS) rate at 6 months
CT scan
Secondary Outcome Measures
Safety profile
outpatient visit, laboratory findings
Response rate and response duration
CT scan
Overall survival
outpatient visit, phone interview
PFS rate at 9 and 18 weeks
CT scan
Identify biomarkers predictive for resistance or sensitivity to trabectedin
tissue, blood, serum collection
Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity
blood samples
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01339754
Brief Title
Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy
Acronym
PACT-18
Official Title
Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
recurrent pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trabectedin
Arm Type
Experimental
Arm Description
1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression
Intervention Type
Drug
Intervention Name(s)
trabectedin
Other Intervention Name(s)
YONDELIS
Intervention Description
1.3 mg/mq as a 3 hour continuous infusion every three weeks
Intervention Type
Drug
Intervention Name(s)
trabectedin
Other Intervention Name(s)
ET 743
Intervention Description
1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) rate at 6 months
Description
CT scan
Time Frame
every 9 weeks
Secondary Outcome Measure Information:
Title
Safety profile
Description
outpatient visit, laboratory findings
Time Frame
every 3 weeks
Title
Response rate and response duration
Description
CT scan
Time Frame
every 2 months
Title
Overall survival
Description
outpatient visit, phone interview
Time Frame
every 3 weeks during therapy, every 2-3 months thereafter
Title
PFS rate at 9 and 18 weeks
Description
CT scan
Time Frame
every 9 weeks
Title
Identify biomarkers predictive for resistance or sensitivity to trabectedin
Description
tissue, blood, serum collection
Time Frame
at trial start
Title
Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity
Description
blood samples
Time Frame
based on a pre-definid sample collection schedule
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Reni, MD
Organizational Affiliation
Istituto Scientifico H. San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Scientifico H. San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy
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