Chemotherapy With or Without Enoxaparin in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— PROSPECT  

Official title:

A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785421
• Other study ID #: CONKO 004
• Secondary ID: CCT-NAPN-16752
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 4, 2008
• Last updated: January 7, 2015
• Start date: April 2004
• Est. completion date: June 2009

Study information

• Verified date: January 2015
• Source: CONKO-Studiengruppe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesGermany: Ministry of Health
• Study type: Interventional

Clinical Trial 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%

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• enoxaparin
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.
• chemotherapy with LMWH - enoxaparin
1-12 weeks: enoxaparin 1g/m², s.c. 12-PD or event: enoxaparin 0,4g s.c.
• only chemotherapy
observation, no treatment with LMWH

Locations

Country	Name	City	State
Germany	Universitätsmedizin - Berlin - Charite	Berlin

Sponsors (4)

Lead Sponsor	Collaborator
CONKO-Studiengruppe	Amgen, Eli Lilly and Company, Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DVT/TVE event rate		After 12 events and after 24 events or after 540 pts recruited	No
Secondary	TTP, OS, side effects		after 12 events and after 24 events or after 540 pts are recruited	No

External Links

•   Link