NCT00024375

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic pancreatic cancer.

Trial Health

60
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
4 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

February 18, 2009

Status Verified

March 1, 2003

First QC Date

September 13, 2001

Last Update Submit

February 17, 2009

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancerstage IV pancreatic cancer

Interventions

DHA-paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed carcinoma of the pancreas * Metastatic disease * Measurable disease * Lesions within a previously irradiated field are not considered measurable * No islet cell tumors, lymphoma, or sarcoma of the pancreas * No known or clinical evidence of CNS metastasis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT or SGPT no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No uncontrolled ventricular arrhythmia * No myocardial infarction within the past 3 months * No superior vena cava syndrome Neurologic: * No peripheral neuropathy greater than grade 1 * No uncontrolled major seizure disorder * No spinal cord compression Other: * No concurrent serious infection requiring parenteral therapy * No unstable or serious concurrent medical condition * No other prior malignancy except: * Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR * Other cancer curatively treated with surgery alone that has not recurred for more than 5 years * No psychiatric disorder that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * No prior chemotherapy for metastatic disease * Prior adjuvant chemoradiotherapy allowed * At least 28 days since prior chemotherapy and recovered * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except megestrol Radiotherapy: * See Disease Characteristics * Prior adjuvant chemoradiotherapy allowed * At least 28 days since prior large-field radiotherapy and recovered * No concurrent radiotherapy Surgery: * At least 14 days since prior major surgery and recovered Other: * No other concurrent anticancer therapy

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

Sponsors & Collaborators

Study Sites (9)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Kliniken Essen - Mitte

Essen, D-45136, Germany

Location

Krankenhaus Nordwest

Frankfurt, D-60488, Germany

Location

Erasmus Medical Center

Rotterdam, 3008 EA, Netherlands

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

docosahexaenoyl-paclitaxel

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Ross C. Donehower, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2001

First Posted

January 27, 2003

Study Start

June 1, 2001

Last Updated

February 18, 2009

Record last verified: 2003-03

Locations

DE(2)NL(1)US(4)GB(2)