NCT00785421

Brief Summary

To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study is powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the experimental arm. N=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%

Trial Health

87
On Track

Trial Health Score

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

Enrollment
312

participants targeted

Target at P75+ for phase_2 pancreatic-cancer

Timeline
Completed

Started Apr 2004

Typical duration for phase_2 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2004

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

4.8 years

First QC Date

November 4, 2008

Last Update Submit

January 7, 2015

Conditions

Pancreatic Cancer

Keywords

heparinLMWHpancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • DVT/TVE event rate

    After 12 events and after 24 events or after 540 pts recruited

Secondary Outcomes (1)

  • TTP, OS, side effects

    after 12 events and after 24 events or after 540 pts are recruited

Study Arms (2)

A

EXPERIMENTAL

Patients with KPS \> 80% and normal kidney function receive GFFC + LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w +/- Enoxaparin 1mg/kg daily s.c.). Pts with KPS \< 80 % and increased creatinin plasma levels (\>1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) + Enoxaparin 1mg/kg daily s.c. After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) + Enoxaparin 40mg/d s.c.

Drug: enoxaparinDrug: chemotherapy with LMWH - enoxaparin

B

ACTIVE COMPARATOR

Patients with KPS \> 80% and normal kidney function receive GFFC - LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w - Enoxaparin 1mg/kg daily s.c.). Pts with KPS \< 80 % and increased creatinin plasma levels (\>1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) - Enoxaparin 1mg/kg daily s.c. After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) - Enoxaparin 40mg/d s.c.

Drug: only chemotherapy

Interventions

enoxaparinDRUG

Patients receive GFFC +/- LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w +/- Enoxaparin 1mg/kg daily s.c.). Pts with KPS \< 80 % and increased creatinin plasma levels (\>1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) +/- LMWM +/- Enoxaparin 1mg/kg daily s.c. After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) +/- Enoxaparin 40mg/d s.c.

Also known as: gemcitabine, cisplatin, folinic acid, 5-FU
A
chemotherapy with LMWH - enoxaparinDRUG

1-12 weeks: enoxaparin 1g/m², s.c. 12-PD or event: enoxaparin 0,4g s.c.

Also known as: gemcitabine, cisplatin, folinic acid, 5-FU
A
only chemotherapyDRUG

observation, no treatment with LMWH

Also known as: gemcitabin, cisplatin, folinic acid, 5-FU
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histological or cytological pancreatic carcinoma, stage IV A, b
  • no preceding radio or chemotherapy of the primarius or the reference lesions
  • Karnofsky performance status ≥ 60%
  • measurable tumor lesion by spiral CT or MRT not older than 14 days
  • no deep venous thrombosis within the last 2 years
  • patient compliance and geographical proximity of the residence, which make an adequate follow up possible
  • sufficient bone marrow reserve: leukocyte ≥ 3.5 × 109 /l, thrombocyte ≥ 100 × 109 /l
  • signed informed consent
  • minimum age of 18 years
  • women/men must provide sufficient pregnancy prevention

You may not qualify if:

  • preexisting indication for anti-coagulation of other reason
  • bleeding in the last 2 weeks or increased bleeding risk (e.g. serious coagulating disturbance, active stomach or intestine ulzera, or had operational interferences in the last 2 weeks)
  • body weight \< 45 kg and/or \> 100 kg
  • pregnancy or insufficient preventing methods in the study process
  • serious illness, which are incompatible with a study participation
  • hypersensitivity to study drugs
  • patients with serious kidney malfunction (Creatininclearance \< 30 ml/min)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsmedizin - Berlin - Charite

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (1)

  • Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

    PMID: 33337539DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

EnoxaparinGemcitabineCisplatinLeucovorinFluorouracilDrug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydratesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesUracilPyrimidinonesTherapeutics

Study Officials

  • Hanno Riess, PHD

    CONKO Study Group

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Uwe Pelzer

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 5, 2008

Study Start

April 1, 2004

Primary Completion

January 1, 2009

Study Completion

June 1, 2009

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

DE(1)