Chemotherapy With or Without Enoxaparin in Pancreatic Cancer (PROSPECT)

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Amgen
Eli Lilly and Company
Information provided by:
CONKO-Studiengruppe
ClinicalTrials.gov Identifier:
NCT00785421
First received: November 4, 2008
Last updated: June 12, 2009
Last verified: June 2009
  Purpose

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%


Condition Intervention Phase
Pancreatic Cancer
Drug: enoxaparin
Drug: chemotherapy with LMWH - enoxaparin
Drug: only chemotherapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT)

Resource links provided by NLM:


Further study details as provided by CONKO-Studiengruppe:

Primary Outcome Measures:
  • DVT/TVE event rate [ Time Frame: After 12 events and after 24 events or after 540 pts recruited ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TTP, OS, side effects [ Time Frame: after 12 events and after 24 events or after 540 pts are recruited ] [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: April 2004
Study Completion Date: June 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A

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: 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.
Other Names:
  • gemcitabine
  • cisplatin
  • folinic acid
  • 5-FU
  • enoxaparin
Drug: chemotherapy with LMWH - enoxaparin
1-12 weeks: enoxaparin 1g/m², s.c. 12-PD or event: enoxaparin 0,4g s.c.
Other Names:
  • gemcitabine
  • cisplatin
  • folinic acid
  • 5-FU
Active Comparator: B

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
observation, no treatment with LMWH
Other Names:
  • gemcitabin
  • cisplatin
  • folinic acid
  • 5-FU

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785421

Locations
Germany
Universitätsmedizin - Berlin - Charite
Berlin, Germany, 13353
Sponsors and Collaborators
CONKO-Studiengruppe
Sanofi
Amgen
Eli Lilly and Company
Investigators
Principal Investigator: Helmut Oettle, PD CONKO Study Group
  More Information

Additional Information:
No publications provided

Responsible Party: Helmut Oettle PD, CONKO Study group
ClinicalTrials.gov Identifier: NCT00785421     History of Changes
Other Study ID Numbers: CONKO 004, CCT-NAPN-16752
Study First Received: November 4, 2008
Last Updated: June 12, 2009
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ministry of Health

Keywords provided by CONKO-Studiengruppe:
heparin
LMWH
pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cisplatin
Heparin, Low-Molecular-Weight
Enoxaparin
Folic Acid
Leucovorin
Levoleucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014