Chemotherapy With or Without Enoxaparin in Pancreatic Cancer

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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%

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CONKO-Studiengruppe
• Collaborators: Amgen; Eli Lilly and Company; Sanofi
• Treatments: Cisplatin; Enoxaparin; Enoxaparin sodium; Fluorouracil; Folic Acid; Gemcitabine; Leucovorin; Levoleucovorin

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)