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

NCT01339754 | Completed Phase 2

• 3 other identifiers: CDR0000698981PACT-182010-024287-17
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; stage IV pancreatic cancer; adenocarcinoma of the pancreas

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) rate at 6 months

  CT scan

  every 9 weeks

Secondary Outcomes (6)

• Safety profile

  every 3 weeks

• Response rate and response duration

  every 2 months

• Overall survival

  every 3 weeks during therapy, every 2-3 months thereafter

• PFS rate at 9 and 18 weeks

  every 9 weeks

• Identify biomarkers predictive for resistance or sensitivity to trabectedin

  at trial start

Study Arms (1)

trabectedin

EXPERIMENTAL

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

Drug: trabectedin

Interventions

trabectedin DRUG

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

Also known as: YONDELIS

trabectedin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Istituto Scientifico H. San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michele Reni, MD

  Istituto Scientifico H. San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 21, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

IT (1)