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

Pancreatic Cancer Clinical Trial

— PACT-18  

Official title:

Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339754
• Other study ID #: CDR0000698981
• Secondary ID: PACT-182010-0242
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2011
• Last updated: August 8, 2014
• Start date: February 2011
• Est. completion date: March 2013

Study information

• Verified date: August 2014
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• trabectedin
1.3 mg/mq as a 3 hour continuous infusion every three weeks
• trabectedin
1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression

Locations

Country	Name	City	State
Italy	Istituto Scientifico H. San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) rate at 6 months	CT scan	every 9 weeks	No
Secondary	Safety profile	outpatient visit, laboratory findings	every 3 weeks	Yes
Secondary	Response rate and response duration	CT scan	every 2 months	No
Secondary	Overall survival	outpatient visit, phone interview	every 3 weeks during therapy, every 2-3 months thereafter	No
Secondary	PFS rate at 9 and 18 weeks	CT scan	every 9 weeks	No
Secondary	Identify biomarkers predictive for resistance or sensitivity to trabectedin	tissue, blood, serum collection	at trial start	No
Secondary	Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity	blood samples	based on a pre-definid sample collection schedule	No