Chemotherapy With or Without Enoxaparin in Pancreatic Cancer (PROSPECT)
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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) |
- DVT/TVE event rate [ Time Frame: After 12 events and after 24 events or after 540 pts recruited ] [ Designated as safety issue: No ]
- 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:
Drug: chemotherapy with LMWH - enoxaparin
1-12 weeks: enoxaparin 1g/m², s.c. 12-PD or event: enoxaparin 0,4g s.c.
Other Names:
|
|
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:
|
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 |
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| Germany | |
| Universitätsmedizin - Berlin - Charite | |
| Berlin, Germany, 13353 | |
| 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 Physiological Effects of Drugs Anticoagulants Hematologic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013