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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Active 18 and over Other, Pharmaceutical / Industry CONKO 004 CCT-NAPN-16752, NCT00785421

Trial Description

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%

Further Study Information

Approximately 20% of patients (pts) diagnosed with pancreatic adenocarcinoma (PA) develop venous thromboembolism, which may contribute to the dismal prognosis of PA. A small phase II trial suggested an improved survival by the addition of low molecular weight heparin (LMWH) to chemotherapy. We conducted a small pilot study which indicated that the addition of enoxaparin to chemotherapy GFFC chemotherapy is safe and feasible in pts with advanced PA. Furthermore, results of several phase III studies suggest that pts in good performance status may benefit from more intensive chemotherapy regimen (Riess et al; Heinemann et al; ASCO 2005). Based on these considerations we started the multicenter phase III study CONKO 004.

540 patients are to be recruited into this study. Primary stratification takes place according to Karnofsky performance status and kidney function. 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) +/- 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.

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Trial Contact Information

Trial Lead Organizations/Sponsors

Charite University Hospital - Campus Virchow Klinikum

Helmut Oettle, PD

Principal Investigator

Helmut Oettle, PD		Ph: +4930450553222
		Email: helmut.oettle@charite.de

Hanno Riess, Prof.		Ph: +4930450553222
		Email: hanno.riess@charite.de

Germany
	Berlin
	Charite University Hospital - Campus Virchow Klinikum
		Uwe Pelzer, MD	Ph: +49450553222
			Email: uwe.pelzer@charite.de
		jens stieler, md	Ph: +4930450553222
			Email: jens.stieler@charite.de

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00785421
Information obtained from ClinicalTrials.gov on November 04, 2008