Condition category
Cancer
Date applied
24/07/2007
Date assigned
21/12/2007
Last edited
11/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.conko-studien.de/

Contact information

Type

Scientific

Primary contact

Dr Helmut Oettle

ORCID ID

Contact details

Augustenburger Platz 1
Berlin
13353
Germany
+49 (0)30 450 553 222
helmut.oettle@charite.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 428; CONKO-004

Study information

Scientific title

Acronym

PROSPECT

Study hypothesis

To reduce thromboembolic events from 10% to 3% within three months with treatment with Enoxaparin.

Ethics approval

Ethical approval granted from the local ethical committee (Charite - Universitaetsmedizin Berlin Ethik-Kommission) on the 29th March 2004 (ref: 69/2004).

Study design

Prospective open multi-centr, randomised controlled phase IIb trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pancreatic cancer

Intervention

After stratification according to Karnofsky Performance Status (KPS), kidney function, tumour stage, recurrent disease, primary disease, DVT in the past patients will be randomised to treatment with/without enoxaparin.

Patients with KPS greater than 80% and normal kidney function receive gemcitabine 1 g/m^2 (30 minutes), cisplatin 30 mg/m^2 (90 minutes), 5-fluorouracil 750 mg/m^2 (24-hours) and folinic acid 200 mg/m^2 (30 minutes) (GFFC), with/without low molecular weight heparin (LMWH) on days 1 and 8 every three weeks with/without enoxaparin 1 mg/kg daily subcutaneously (sc).

Patients with KPS less than 80% and increased creatinine plasma levels (greater than 1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m^2 (30 minutes) on days 1, 8 and 15 every four weeks) with/without enoxaparin 1 mg/kg daily sc.

After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine 1 g/m^2 (30 minutes) on days 1, 8 and 15 every four weeks) with/without enoxaparin 40 mg daily sc.

Intervention type

Drug

Phase

Phase II/III

Drug names

Enoxaparin

Primary outcome measures

To reduce thromboembolic events from 10% to 3% within three months (Kaplan Meyer estimation).

Secondary outcome measures

1. Reduction of thromboembolic rate at timepoints 6, 9 and 12 months (Kaplan Meyer estimation)
2. Time to progression
3. Overall survival, progression free survival: Kaplan Meyer Plot (current version of SPSS)
4. Rate of remission: description with tabulations, as percentage of the two treatment groups, duration of remission
5. Toxicity: National Cancer Institute (NCI) Common Toxicity Criteria (CTC) grade differentation, description with tabulations
6. Quality of life: tabulation descriptions, assesment with box-plot (current version of SPSS)

Overall trial start date

01/04/2004

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically or cytologically proven advanced pancreatic cancer stage Iva, b
2. No previous tumour specific therapy of the main tumor or distant metastases
3. Karnofsky Performance Status (KPS) greater than 50%
4. Measurable disease visible per computed tomography (CT) or magnetic resonance tomography (MRT) not older than 14 days
5. No previous deep vein thrombosis (DVT) of the legs within last two years
6. Leucocytes greater than 3.5 x 10^9/L, platelets greater than 100 x 10^9/L
7. Written informed consent
8. Age of 18 years or more
9. Sufficient contraception up to six months after the end of therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

540

Participant exclusion criteria

1. Indication for anticoagulation therapy
2. Previous bleeding within two weeks before or increased danger of bleeding
3. Body weight less than 45 kg or greater than 100 kg
4. Pregnant or breastfeeding women
5. Heavy disorders, contradictory with study (as decided by physician)
6. Hyperesthesia against study medication or related drugs
7. Patients with renal failure (creatinine clearance less than 30 ml/min)

Recruitment start date

01/04/2004

Recruitment end date

01/04/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Augustenburger Platz 1
Berlin
13353
Germany

Sponsor information

Organisation

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Sponsor details

Augustenburger Platz 1
Berlin
13353
Germany
+49 (0)30 450 553 222
lars.roll@charite.de

Sponsor type

University/education

Website

http://www.charite.de/de

Funders

Funder type

Industry

Funder name

Sanofi-Aventis Deutschland GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Lilly Deutschland GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19055847

Publication citations

  1. Protocol

    Riess H, Pelzer U, Hilbig A, Stieler J, Opitz B, Scholten T, Kauschat-Brüning D, Bramlage P, Dörken B, Oettle H, Rationale and design of PROSPECT-CONKO 004: a prospective, randomized trial of simultaneous pancreatic cancer treatment with enoxaparin and chemotherapy)., BMC Cancer, 2008, 8, 361, doi: 10.1186/1471-2407-8-361.

Additional files

Editorial Notes