Patients with metastatic or inoperable renal cell cancer
Conditions
Interventions
Trade Name: 1) SUTENT (Sunitinib Maleate) Capsules, Pfizer Inc., LAB-0317-2.0
Product Name: Sunitinib maleate
Pharmaceutical Form: Capsule*
Trade Name: Fragmin, Pfizer Inc., LAB-0058-7.0
Product Name
Sponsors
VU Medical Center Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 3.1 Inclusion Criteria 1) Patients must have histologically confirmed metastatic or unresectable renal cell carcinoma. 2) Clear cell and non-clear renal carcinoma patients are eligible. Oncocytoma, collecting duct tumors and transitional cell carcinoma are NOT eligible. 3) No prior systemic treatments for metastatic disease are permitted, including antiangiogenic therapy, immunotherapy, chemotherapy and investigational therapy. 4) Patients with their primary tumor in place who are appropriate surgical candidates should be strongly encouraged to undergo nephrectomy prior to treatment initiation, based on the potential effect on survival. 6) Prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been radiated. 7) Radiation therapy must be completed >4 weeks prior to registration 8) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as >20 mm with conventional techniques or as >10 mm with spiral CT scan (RECIST criteria). 9) Age > 18 years. 10) ECOG performance status = 2. 11) Patients must have normal organ and marrow function as defined below: • leukocytes >3,000/mm3 • absolute neutrophil count >1,500/mm3 • platelets >100,000/mm3 • total bilirubin 50 ml/min/1.73m2 • PT/INR 1+, 24 hour urine protein should be obtained and should be =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Prior therapy with Sunitinib. 2) Patients may not be receiving any other investigational agents. 3) Patients with known CNS metastases. Patients should have a head CT/MRI within 14 days prior to treatment initiation. Any imaging abnormality indicative of CNS metastases will exclude the patient from the study. 4) Patients with a “currently active” second malignancy other than non-melanoma skin cancers are not eligible. Patients are not considered to have a “currently active” malignancy if they have completed anti-cancer therapy and are considered by their physician to be at less than 30% risk of relapse. 5) Patients with a large (>2cm) pulmonary lesion involving the trachea or one of the main bronchus and any endobronchial lesion. 6) History of allergic reactions attributed to compounds of similar chemical or biologic composition to Dalteparin. 7) Evidence of bleeding diathesis within last 6 months. 9) Serious or non-healing wound, ulcer or bone fracture or active peptic ulceration. 10) Current therapeutic full-dose of anticoagulants, either warfarin or LMWH or unfractionated heparin. 11) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Association Class II, III, or IV), angina pectoris requiring nitrate therapy, recent myocardial infarction (160 mmHg systolic and/or >90 mmHg diastolic on medication), hemorrhagic retinopathy, history of peripheral vascular disease, or psychiatric illness/social situations that would limit compliance with study requirements. 12) Patients with an ejection fraction <50% by MUGA scan are not eligible. 13) Pregnant women are excluded from this study because Sunitinib is an angiogenesis inhibitor agent with the potential for teratogenic or abortion inducing effects. 14) History of abdominal fistula, gastrointestinal perforation or intra-abdominal abcess within 28 days prior to day 1 therapy. 15) Invasive procedures defined as: -Major surgical procedure, open biopsy, or significant traumatic injury within 6 weeks prior to day 1 therapy. -Anticipation of need for major surgical procedures during the course of the study. -Core biopsy within 7 days prior to start therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.1 Objectives phase I study 1 To determine the recommended dosing for the combination of Sunitinib and Dalteparin in patients with metastatic renal cell carcinoma. 2 To evaluate safety and tolerability for the combination of Sunitinib and Dalteparin in patients with metastatic renal cell carcinoma. 3 To determine early signs of clinical activity of the combination of Sunitinib and Dalteparin in patients with metastatic renal cell carcinoma. 1.2 Primary Objectives phase II study 1 To determine the proportion of patients with metastatic renal cell carcinoma receiving the combination of Sunitinib and Dalteparin as first line treatment, that is progression-free at 11 months. 2 To determine the safety of the combination of Sunitinib and Dalteparin in patients with metastatic renal cell carcinoma. ;Secondary Objective: 1.3 Secondary Objectives for phase I and phase II studies 1 To determine the clinical response rate of Sunitinib and Dalteparin in patients with metastatic renal cell carcinoma. 2 To determine time-to-progression (TTP) and overall survival amongst patients with metastatic renal cell carcinoma receiving Sunitinib and Dalteparin. 3 To determine the effect of Sunitinib alone and Dalteparin alone compared to the combination of Dalteparin plus Sunitinib on plasma coagulation parameters. 4 To determine the effect of Sunitinib alone and Dalteparin alone compared to the combination of Dalteparin plus Sunitinib on angiogenesis parameters in blood. 5 To evaluate the modulation of tumor blood volume and vascular permeability in patients treated with Sunitinib and Dalteparin by DCE-MRI. ;Primary end point(s): 7.1 Primary Objectives Phase I part 1 To determine the recommended dosing for the combination of Dalteparin and Sunitinib in patients with metastatic renal cell carcinoma. 2 To evaluate safety and tolerability for the combination of Dalteparin and Sunitinib in patients with metastatic renal cell carcinoma. 3. To determine early signs of clin | — |
Countries
Netherlands
Outcome results
None listed