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

NCT ID: NCT01339754

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-03-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

trabectedin

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

Group Type: EXPERIMENTAL

trabectedin

Intervention Type: DRUG

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

trabectedin

Intervention Type: DRUG

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

Interventions

trabectedin

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

Intervention Type: DRUG

trabectedin

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

Intervention Type: DRUG

Other Intervention Names

YONDELIS; ET 743

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Michele Reni

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Reni, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Scientifico H. San Raffaele

Locations

Istituto Scientifico H. San Raffaele

Milan, , Italy

Countries

Italy

Other Identifiers

PACT-18

Identifier Type: OTHER

Identifier Source: secondary_id

2010-024287-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDR0000698981

Identifier Type: -

Identifier Source: org_study_id