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Cervical CancerPhase 3NCT00006083

Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter

A Phase 3 study testing Fragmin in people with Cervical Cancer and Chronic Myeloproliferative Disorders, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is effective in reducing these complications. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fragmin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
Not given
Where
1 siteUnited States
Study dates
Apr 2000to Nov 2000
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed malignancy
  • No more than 5 days since placement of central venous catheter for administration of chemotherapy
  • Expected length of catheter use at least 16 weeks
  • 18 and over
  • Performance status: ECOG 0-2
  • Life expectancy: At least 16 weeks
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  • Hematopoietic:
  • Platelet count at least 100,000/mm3
  • Absolute neutrophil count at least 1,500/mm3
  • No known coagulopathy
  • Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) except in case of Gilbert's syndrome
  • AST no greater than 3 times ULN (no greater than 5 times ULN in case of liver metastases)
  • PT/PTT no greater than 1.5 times ULN Renal:
  • Creatinine no greater than 2 times ULN Cardiovascular:
  • HIV negative
  • Must weigh at least 90 pounds
  • At least 3 months since prior eye, ear, or CNS surgery Other:
  • At least 30 days since prior aspirin, dipyridamole, unfractionated heparin, other low molecular weight heparins, or other anticoagulation therapy (except heparin flushing)

Who cannot join

  • uncontrolled hypertension, unstable angina, or symptomatic congestive heart failure
  • myocardial infarction in past 6 months
  • uncontrolled cardiac arrhythmia Other:
  • known hypersensitivity (including heparin induced thrombocytopenia) to dalteparin, heparin, or other low molecular weight heparins
  • active uncontrolled infection, including existing catheter related infection
  • CNS trauma in past 3 months
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  • retinal detachment in past 6 months
  • mental incapacitation or psychiatric illness that would preclude study compliance
  • other serious concurrent disease that would preclude study participation
  • active gastrointestinal or genitourinary tract bleeding
  • intracranial or intraocular hemorrhage in past year
  • concurrent high dose chemotherapy with stem cell transplantation
  • concurrent induction/consolidation chemotherapy for leukemia
  • concurrent high dose chemotherapy with stem cell transplantation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

Official title: A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Fragmin (5,000 IU Subcutaneously) in Preventing Catheter-Related Complications When Given Daily to Cancer Patients With Central Venous Catheters

RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is effective in reducing these complications.

PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter.

Read the detailed description

OBJECTIVES: I. Determine if dalteparin will reduce the incidence of clinically significant catheter related complications (i.e., asymptomatic catheter related thrombosis) in cancer patients receiving chemotherapy through a central venous catheter.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to treatment center and catheter placement (proximal to axilla vs distal to axilla). Patients are randomized to one of two treatment arms. Arm I: Patients receive dalteparin subcutaneously (SC) daily. Arm II: Patients receive placebo SC daily. Treatment continues for 16 weeks or until catheter removal in the absence of unacceptable toxicity. Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 345 patients (230 in arm I and 115 in arm II) will be accrued for this study over 6 months.

Being tested
Fragmin, placebo
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, monoclonal gammopathy of undetermined significance, recurrent adult Hodgkin lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, stage IB cervical cancer, Burkitt lymphoma, isolated plasmacytoma of bone, extramedullary plasmacytoma, refractory multiple myeloma, stage 0 chronic lymphocytic leukemia, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Medical subject headings
Uterine Cervical Neoplasms, Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Precancerous Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FragminDrug

    Fragmin at 5000 IU injected subcutaneously daily

  • placeboOther

    placebo injected subcutaneously daily

Study groups in NCT00006083
Study groupRoleWhat they receive
FragminExperimentalFragmin at 5000 IU injected subcutaneously daily
Receives: Drug: Fragmin
placeboPlacebo comparatorplacebo injected subcutaneously daily
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine if 5000 IU of Fragmin administered daily when compared to placebo will reduce the incidence of clinically relevant CRCs in cancer patients receiving chemotherapy by CVC

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2004 (estimated)
  2. Study startApr 2000
  3. Primary completionNov 2000
  4. Study completionNov 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006083
Sponsor's protocol ID
CDR0000068075
Other IDs
UCLA-9910055, P-UPJOHN-98-FRAG-076, NCI-G00-1822
Status last verified
Jul 2012
First submitted
3 Aug 2000
Last updated
3 Aug 2020
Results posted
No
Data monitoring committee
Yes

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