Status:
COMPLETED
Phase II Study of Alternating Sunitinib and Temsirolimus
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In the past 5 years, treatment for metastatic Renal Cell Carcinoma (mRCC) has focused on agents directed at blocking tumor and vascular growth pathways. Sunitinib blocks the vascular endothelial growt...
Detailed Description
SUMMARY: Alternating Targeted Therapy in Patients with Metastatic Renal Cell Carcinoma: A Phase II Study of Alternating Sunitinib and Temsirolimus Patients with measurable metastatic renal cell carci...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically confirmed metastatic renal cell cancer with evaluable disease.
- Patients must be at least 2 weeks from their last immunotherapy, surgery or chemotherapy (6 weeks for nitrosureas) and recovered from all ill effects.
- Karnofsky Performance Status ≥60%
- Life expectancy ≥ twelve weeks
- Adequate end organ function:
- Cardiac Left ventricular ejection fraction (LVEF) ≥lower limit of institutional normal (LLN) as assessed by echocardiography (ECHO) . The same modality used at baseline must be applied for subsequent evaluations.
- Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study and practicing acceptable forms of birth control
- Appropriate Contraception in both sexes
- The patient must be competent and signed informed consent.
- EXCLUSION CRITERIA
- Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS.
- In patients with a prior history of invasive malignancy, less than five years in complete remission.
- Have evidence of significant co-morbid illness such as uncontrolled diabetes, hypertension or active infection that would preclude treatment on this regimen.
- Prior treatment with either sunitinib or temsirolimus
- Clinically significant gastrointestinal abnormalities
- Presence of uncontrolled infection.
- Prolongation of corrected QT interval (QTc) \> 480 milliseconds - History of any one or more of the following cardiovascular conditions within the past 12 months:
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Coronary artery by-pass graft surgery
- Symptomatic peripheral vascular disease
- Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- History of cerebrovascular accident (CVA) including transient ischemic attack (TIA) within the past 12 months.
- History of pulmonary embolism or untreated deep venous thrombosis (DVT)within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anticoagulating agents for at least 6 weeks are eligible.
- Poorly controlled hypertension \[defined as systolic blood pressure (SBP) of
- ≥150 or diastolic blood pressure (DBP) of ≥ 90. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry.
- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
- Evidence of active bleeding or bleeding diathesis
- Hemoptysis within 6 weeks of first dose of study drug.
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study.
- Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug any minor surgeries (i.e. skin biopsy, tooth extraction, etc.) and recovered from all ill effects.
- Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to sunitinib or temsirolimus.
- Untreated brain metastasis. (Brain metastases that are stable based on radiographic evidence 4 weeks after radiation and/or surgery are permitted).
Exclusion
Key Trial Info
Start Date :
September 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2018
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01517243
Start Date
September 22 2010
End Date
August 20 2018
Last Update
September 21 2023
Active Locations (2)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
2
University of Vermont, Vermont Cancer Center
Burlington, Vermont, United States, 05401