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

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Completed

CT.gov ID

NCT01339754

Collaborator

(none)

Enrollment

Location

Arm

24.9

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: trabectedin Drug: trabectedin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

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 Other Names: YONDELIS Drug: trabectedin 1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression Other Names: ET 743

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

Other Names:

YONDELIS

Drug: trabectedin

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

Other Names:

ET 743

Outcome Measures

Primary Outcome Measures

Progression-free survival (PFS) rate at 6 months [every 9 weeks]
CT scan

Secondary Outcome Measures

Safety profile [every 3 weeks]
outpatient visit, laboratory findings
Response rate and response duration [every 2 months]
CT scan
Overall survival [every 3 weeks during therapy, every 2-3 months thereafter]
outpatient visit, phone interview
PFS rate at 9 and 18 weeks [every 9 weeks]
CT scan
Identify biomarkers predictive for resistance or sensitivity to trabectedin [at trial start]
tissue, blood, serum collection
Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity [based on a pre-definid sample collection schedule]
blood samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michele Reni, MD, IRCCS San Raffaele

ClinicalTrials.gov Identifier:

NCT01339754

Other Study ID Numbers:

CDR0000698981
PACT-18
2010-024287-17

First Posted:

Apr 21, 2011

Last Update Posted:

Aug 11, 2014

Last Verified:

Aug 1, 2014

Keywords provided by Michele Reni, MD, IRCCS San Raffaele

recurrent pancreatic cancer

stage IV pancreatic cancer

adenocarcinoma of the pancreas

Additional relevant MeSH terms:

Pancreatic Neoplasms

Trabectedin

Study Results

No Results Posted as of Aug 11, 2014