Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00031837
Other study ID # CDR0000069232
Secondary ID URCC-U2200NCI-50
Status Terminated
Phase Phase 3
First received March 8, 2002
Last updated October 13, 2015
Start date October 2002
Est. completion date December 2006

Study information

Verified date October 2015
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

OBJECTIVES:

- Compare the quality of life of patients with unresectable or metastatic pancreatic cancer treated with gemcitabine with or without dalteparin.

- Compare the survival of patients treated with these regimens.

- Compare the incidence of venous thromboembolic complications in patients treated with these regimens.

- Determine the safety of dalteparin, in terms of bleeding complications, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (unresectable nonmetastatic vs metastatic). Patients are randomized to one of two treatment arms.

- Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 for the first course only. Beginning on week 9, patients receive gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment then repeats every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression.

- Arm II: Patients receive gemcitabine as in arm I and dalteparin subcutaneously once daily for 6 months in the absence of unacceptable toxicity.

Quality of life is assessed at baseline and every 4 weeks during study therapy.

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 40 months.


Recruitment information / eligibility

Status Terminated
Enrollment 400
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 120 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
dalteparin

gemcitabine hydrochloride

Procedure:
quality-of-life assessment


Locations

Country Name City State
United States MBCCOP - University of Illinois at Chicago Chicago Illinois
United States CCOP - Columbus Columbus Ohio
United States CCOP - Dayton Dayton Ohio
United States CCOP - Central Illinois Decatur Illinois
United States CCOP - Colorado Cancer Research Program, Incorporated Denver Colorado
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States CCOP - Southeast Cancer Control Consortium Goldsboro North Carolina
United States CCOP - Greenville Greenville South Carolina
United States CCOP - Kalamazoo Kalamazoo Michigan
United States CCOP - Kansas City Kansas City Missouri
United States MBCCOP - Gulf Coast Mobile Alabama
United States University of Rochester Cancer Center CCOP Research Base Rochester New York
United States CCOP - Northwest Tacoma Washington

Sponsors (2)

Lead Sponsor Collaborator
Gary Morrow National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life as measured by FACT-Hep version 4 every 4 weeks No
Secondary Survival No
Secondary Frequency of symptomatic venous thromboembolic complications No
Secondary Safety as measured by the occurrence of bleeding complications Yes
See also
  Status Clinical Trial Phase
Completed NCT05305001 - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Recruiting NCT06054984 - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04927780 - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer Phase 3
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Terminated NCT03140670 - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy Phase 2
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05168527 - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05391126 - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care N/A
Terminated NCT03300921 - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer Phase 1
Completed NCT03153410 - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas Early Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT05679583 - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer Phase 2
Recruiting NCT04183478 - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer Phase 2/Phase 3
Terminated NCT03600623 - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Completed NCT04290364 - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study