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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Treatments: Trabectedin

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