Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate Cancer

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Thrombosis, Venous

Treatments: Drug: Nadroparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00312013

FRX106365

Details and patient eligibility

About

This study will evaluate the effects of nadroparin on survival and disease progression in patients with hormone-refractory prostate cancer (HRPC), locally advanced pancreatic cancer or non-small-cell lung carcinoma (NSCLC).

Enrollment: 503 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hormone refractory prostate cancer within 6 months of diagnosis, OR locally advanced (non-metastasized) pancreatic cancer within 3 months of diagnosis, OR non-small-cell lung cancer within 3 months of stage IIIB.

Exclusion criteria

• Life expectancy of <3 months.
• Poor performance status (Karnofsky <60).
• Need to be on anticoagulants.
• Use of nadroparin (a low molecular weight heparin) for any reason including a history of heparin-induced thrombocytopenia.
• Have brain metastasis.
• At a high risk of bleeding or have a platelet count <50,000/mm3.
• Have very poor kidney function.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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503 participants in 2 patient groups

No Nadroparin

No Intervention group

Description:

Patients will receive all standard anticancer treatment. Patients in this arm will not receive nadroparin

Nadroparin

Experimental group

Description:

Patients will be randomized to receive standard anticancer treatment. Nadroparin patients will be treated with therapeutic doses of subcutaneous (s.c). nadroparin for 2 weeks followed by half therapeutic doses for 4 weeks. After 4 weeks of wash-out, subsequent 2-week periods of therapeutic doses of nadroparin will be given for a total of 6 cycles each separated by a 4-week wash-out. The study treatment period ends at week 46 regardless of number of cycles achieved at that moment.

Treatment:

Drug: Nadroparin