Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial
2 other identifiers
interventional
180
1 country
1
Brief Summary
The goal of this clinical research study is to compare 6 different 2-drug "sequences" of everolimus, bevacizumab, or pazopanib to learn how they may affect metastatic kidney cancer. For the 2-drug sequence, participants will receive 1 of these drugs and may start taking another of these drugs after that. Researchers will also study the safety of these 2-drug sequences.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2010
CompletedFirst Posted
Study publicly available on registry
October 8, 2010
CompletedStudy Start
First participant enrolled
January 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
January 30, 2026
January 1, 2026
17 years
October 7, 2010
January 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Overall Treatment Failure
Measured from date of randomization to date of second disease progression, 'drop-out' from protocol treatment for any reason or death, associated with each of the six two-agent sequential therapies given in parallel.
4 weeks
Study Arms (6)
Group 1
EXPERIMENTALPazopanib + possible Bevacizumab
Group 2
EXPERIMENTALPazopanib + possible Everolimus
Group 3
EXPERIMENTALEverolimus + possible Bevacizumab
Group 4
EXPERIMENTALEverolimus + possible Pazopanib
Group 5
EXPERIMENTALBevacizumab + possible Pazopanib
Group 6
EXPERIMENTALBevacizumab + possible Everolimus
Interventions
800 mg by mouth once daily for 28 days. A cycle consists of 4 weeks.
10 mg/kg by vein every two weeks. A cycle consists of 4 weeks.
10 mg by mouth once daily. A cycle consists of 4 weeks.
Eligibility Criteria
You may qualify if:
- Confirmed metastatic RCC with a clear cell component.
- Prior radical or partial nephrectomy required. Patients whose primary tumor was treated with cryoablation or radiofrequency ablation would also be eligible.
- Measurable disease
- Age \>/= 18 years. Because no dosing or adverse event data are currently available on the use of these targeted agents in patients \< 18 years of age, children are excluded from this study
- ECOG performance status 0 or 1
- Adequate organ and marrow function within 14 days as defined below: a) Absolute neutrophil count /=\> 1,500/microL; b) Platelets \>/= 100,000/microL; c) Hgb \>/= 9.0 g/dL (transfusion allowed); d) Total bilirubin \< 1.5 mg/dl; e) Albumin \> 2.5 g/dL; f) AST and ALT \</= 2.5 X ULN for subjects without liver metastases; g) AST and ALT \< 5 X ULN for subjects with liver metastases; h) Serum creatinine \</= 2 mg/dL or CrCl \>/= 50 cc/min; i) Fasting serum cholesterol \</= 300 mg/dL or \</= 7.75 mmol/L and fasting triglycerides \</= 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
- Female patients of childbearing potential must have a negative pregnancy test (serum/plasma or urine) within 7 days prior to beginning treatment on the study due to the possible teratogenic effect
- Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study
- Patients must give written informed consent prior to initiation of study-related procedures. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy
- Patients must be able to swallow pills
- Both men and women and members of all races and ethnic groups are eligible for this trial
You may not qualify if:
- No patient with any concurrent active malignancy, i.e. a patient requiring or receiving systemic therapy for another malignancy at the same time of treatment for RCC
- Patients must not have received any prior targeted therapy (anti-VEGF agents or mTOR inhibitors), including adjuvant therapy, and must not have received any prior chemotherapy for mRCC. However, patients who had received prior immunotherapy, such as cytokines or vaccines, are permitted to enroll.
- Patients must not be scheduled to receive another experimental drug while on this study. Patients are permitted to receive concomitant bisphosphonates.
- Patients must not have multiple brain metastases or leptomeningeal disease. Patients with controlled solitary brain metastasis are eligible.
- Patients must not have had a stroke or transient ischemic attack within 6 months.
- Patients must not have uncontrolled infections.
- Patients must not have clinically significant cardiovascular disease, defined as myocardial infarction (or unstable angina) within 6 months, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia refractory to medical management
- Patients must not have uncontrolled hypertension, defined as \> 140/90 or prior history of hypertensive crisis or hypertensive encephalopathy. Treatment of hypertension with medications is permitted.
- History of hemoptysis (\>/= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Symptomatic peripheral vascular disease
- Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breast-feeding should be discontinued if the mother is enrolled on this trial.
- Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with some of these agents.
- Patients must not have a clinical history of coagulopathy or bleeding diathesis. Patients may be on therapeutic anticoagulation preferably a low-molecular weight heparin. If the patients are on warfarin, the INR should be maintained within a therapeutic level and must be checked weekly for the first four weeks, then every 2 weeks for 4 additional weeks. Thereafter, they may be followed at the discretion of the treating provider. Antiplatelet agents are allowed.
- Concomitant treatment with rifampin, St. John's wort, or the cytochrome p450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or Phenobarbital) is not allowed on this study.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Novartiscollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amado Zurita, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2010
First Posted
October 8, 2010
Study Start
January 19, 2011
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
January 31, 2028
Last Updated
January 30, 2026
Record last verified: 2026-01