NCT00031837

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Anticoagulants such as dalteparin may help prevent blood clots in patients being treated with gemcitabine for unresectable or metastatic pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without dalteparin in treating patients who have unresectable or metastatic pancreatic cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for phase_3 pancreatic-cancer

Timeline
Completed

Started Oct 2002

Geographic Reach
1 country

13 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2002

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

4.2 years

First QC Date

March 8, 2002

Last Update Submit

October 13, 2015

Conditions

Pancreatic CancerThromboembolism

Keywords

thromboembolismstage III pancreatic cancerrecurrent pancreatic canceradenocarcinoma of the pancreasstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of life as measured by FACT-Hep version 4 every 4 weeks

Secondary Outcomes (3)

  • Survival

  • Frequency of symptomatic venous thromboembolic complications

  • Safety as measured by the occurrence of bleeding complications

Study Arms (1)

Dalteparin

EXPERIMENTAL

5,000 anti-Xa units of dalteparin subcutaneously once daily for six months in addition to gemcitabine at 1,000 mg/m2 as a 30-minute infusion weekly for 7 weeks followed by a week of rest for the first cycle and weekly for three weeks followed by a week of rest for each subsequent cycle.

Drug: dalteparinDrug: gemcitabine hydrochlorideProcedure: quality-of-life assessment

Interventions

dalteparinDRUG
Dalteparin
gemcitabine hydrochlorideDRUG
Dalteparin
quality-of-life assessmentPROCEDURE
Dalteparin

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma of the pancreas that is considered ineligible for curative resection PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Eastern Cooperative Oncology Group 0-2 Life expectancy: * Not specified Hematopoietic: * White Blood Cell count greater than 3,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * No clinically significant bleeding disorder * No prior heparin-induced thrombocytopenia Hepatic: * Bilirubin less than 2.0 mg/dL * aspartate aminotransferase less than 3 times normal Renal: * Creatinine less than 2.0 mg/dL Cardiovascular: * No prior hemorrhagic stroke * No uncontrolled hypertension (sustained blood pressure greater than 200 mm Hg systolic or 110 mm Hg diastolic) Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other active malignancy * No gastrointestinal bleeding within the past 30 days * No contraindications to anticoagulation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for metastatic disease * Prior adjuvant chemotherapy allowed Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * Prior surgical resection allowed * At least 4 weeks since prior surgery with non-curative intent and recovered * More than 30 days since prior neurologic or ophthalmologic surgery Other: * At least 2 weeks since prior low-molecular-weight heparin * More than 30 days since prior experimental therapeutic agent * No concurrent heparin or warfarin for pre-existing condition

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

Sponsors & Collaborators

Study Sites (13)

MBCCOP - Gulf Coast

Mobile, Alabama, 36607, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612-7323, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

University of Rochester Cancer Center CCOP Research Base

Rochester, New York, 14642, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsThromboembolism

Interventions

DalteparinGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydratesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Kishan J. Pandya, MD

    University of Rochester

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, URCC CCOP Research Base

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

October 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

US(13)