Tinzaparin in Treating Patients With Metastatic Kidney Cancer That Cannot Be Removed By Surgery

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed renal cell carcinoma of clear cell histology
• •* No nonclear cell histologies, collecting duct tumors, oncocytomas, or transitional cell tumors
• •Metastatic and unresectable disease that is clinically extending beyond the regional lymph nodes (histological confirmation not required)
• •* Patients who are inoperable for their primary tumor representing the sole site of disease are ineligible
• •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan
• •No known brain metastases
• •PATIENT CHARACTERISTICS:
• •Expected survival \> 2 months
• •CALGB (ECOG/ZUBROD) performance status (PS) 0-2 OR Karnofsky PS 60-100%
• •Hemoglobin ≥ 10 g/dL
• •Platelet count ≥ 100,000/mm\^3
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• •AST/ALT ≤ 1.5 times ULN
• •Creatinine ≤ 1.5 times ULN
• •INR ≤ 1.5 times control value
• •PTT \< 1.5 times control value
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •Patients must be able to receive subcutaneous injections at home
• •No other primary malignancy in the past 5 years other than basal cell carcinoma or carcinoma in situ of the cervix that has been curatively treated and is associated with a less than 30% risk of relapse in the next 5 years
• •No signs or symptoms of bleeding within 4 the past weeks
• •No known bleeding diathesis or high risk for bleeding due to any condition, including trauma within the past 4 weeks, active current bleeding, or hemorrhagic stroke or intraocular bleeding within the past 6 months
• •No active thromboembolism highly likely to require anticoagulation during the study period
• •No known or suspected history of type II heparin-induced thrombocytopenia
• •No allergy or hypersensitivity to heparin, tinzaparin sodium, pork products, sulfite, or benzyl alcohol
• •No uncontrolled severe intercurrent illness, including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• •No uncontrolled arterial hypertension, history of gastrointestinal ulceration, and/or bleeding in the past 4 weeks
• •No diabetic retinopathy or history of retinal hemorrhage
• •Not pregnant or nursing
• •HIV-positive patients are allowed
• •PRIOR CONCURRENT THERAPY:
• •No treatment with anticoagulation lasting \> 1 month in the past 6 months
• •No anticoagulation, including treatment with a low molecular weight heparin, at any time within the past month
• •More than 4 weeks since prior surgery, radiation therapy, immunotherapy, or chemotherapy
• •Recovered from prior therapy
• •No other concurrent investigational agents
• •No other concurrent anticoagulation therapy, including oral anticoagulants, thrombolytic agents, or any form of heparin
• •* Concurrent antiplatelet agents allowed
• •No spinal or epidural puncture, anesthesia, or post-operative indwelling epidural catheters within the past 48 hours
• •No other concurrent anticancer agents or therapies
• •No concurrent sex hormones except for postmenopausal hormone replacement
• •No concurrent chemotherapy or immunotherapy
• •No concurrent palliative radiotherapy
• •Concurrent urgent use of corticosteroids allowed