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

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed renal cell carcinoma of clear cell histology

  • Tumors of mixed histology eligible if ≥ 50% of tumor has 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