Overview

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