Study of Combination of Sirolimus and Sutent in Patients With Advanced Solid Tumors Non-Curable With Standard Therapy
NCT00402415
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- Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. Patients with previously untreated metastatic renal cell carcinoma are eligible.
- Patients must have measurable disease by RECIST criteria.
- Patients must have at least 1 lesion located in the neck, lung, solid organ (including liver) or soft tissue in abdomen or pelvis, or soft tissue in lower extremities that is 3 cm and ideally <7 cm in the transaxial plane. Larger lesions may be considered if they meet all other criteria. Index lesions must be well demarcated.
- ECOG performance status of 0-1.
- Must be ≥18 years of age.
- Expected survival of at least 3 months.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods. Pregnant and nursing patients are excluded because the effects of the combination of SU11248 (Sutent®) and sirolimus on a fetus or nursing child are unknown.
- Must be able and willing to give written informed consent.
- Patients must have the following clinical laboratory values: ANC count ≥1500/mm3; Platelets ≥100,000/mm3; Serum creatinine ≤2x upper limit of normal. If serum creatinine is above the upper limit of normal (but less than 2x normal), patients must have a measured 24 hour urine creatinine clearance ≥ 50 ml/min to be eligible; Total bilirubin < 1.5x upper limit of normal; Serum calcium < 12.0 mg/dl; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3x the upper limit of normal; Prothrombin Time (PT), activated partial thromboplastin time (aPTT) and INR in the normal range;. Hemoglobin ≥9 gm/dl (may be corrected by transfusion).
- Normal cardiac ejection fraction
- Diagnosis or history of central nervous system (CNS) disease (i.e. primary brain
tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
- Any active uncontrolled bleeding and any patient with a bleeding diathesis (for
example, active peptic ulcer disease). Any grade 3 hemorrhage within 4 weeks prior to
starting treatment.
- Any ongoing coagulopathies or receiving anticoagulants.
- Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal
medical therapy).
- QTc interval > 500 msec on baseline EKG.
- Cardiac ejection fraction below institutional lower limit of normal.
- Measured 24-hour urine creatinine clearance < 50 ml/min.
- Active infection of any kind.
- Unwilling or unable to follow protocol requirements or to give informed consent.
- Dyspnea at rest or with minimal exertion.
- No treatment with cytotoxic or biologic agents within the 4 weeks prior to beginning
treatment on this study (6 weeks for mitomycin or nitrosoureas). At least 4 weeks must
have elapsed from any prior surgery, radiation, hormonal or other drug therapy for
their cancer. Patients must have fully recovered from the acute toxicities of any
prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities
(returned to baseline status as noted before most recent treatment). Patients with
persisting, stable chronic toxicities from prior treatment ≤ grade 1 are eligible.
- Any of the following within 6 months prior to first dose of treatment: myocardial
infarction, symptomatic coronary artery disease (severe or unstable angina), artery
bypass graft, uncontrolled arrhythmias, symptomatic congestive heart failure,
cerebrovascular accident or transient ischemic attack, or pulmonary embolus.
- Known HIV infection. Patients with HIV infection are excluded because there may be
unknown or dangerous drug interactions between sirolimus/SU11248 (Sutent®) and the
anti-retroviral agents used to treat HIV infections.
- Patients receiving any other standard or investigational treatment for their cancer,
or any other investigational agent for any indication.
- Diagnosis of second malignancy (except malignancies treated with no evidence of
recurrence for at least 5 years, and curatively treated basal cell or squamous cell
carcinomas of the skin, or in situ cervical cancer, or any stage I malignancy > 2
years from treatment).
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results, and in
the judgment of the investigator would make the subject inappropriate for entry into
this study.
- Patients taking concurrent medications of any kind which are strong inducers or
inhibitors of CYP3A4. Patients receiving any of the following will be excluded:
ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone,
nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, dexamethasone,
phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's
Wort.
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Descriptive Information | ||||
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Brief Title ICMJE | Study of Combination of Sirolimus and Sutent in Patients With Advanced Solid Tumors Non-Curable With Standard Therapy | |||
Official Title ICMJE | A Phase I Trial of the Combination of Sirolimus and SU11248 (Sutent(R)) in Patients With Advanced Solid Tumors That Are Non-Curable With Standard Therapy | |||
Brief Summary | There are two drugs involved in this study. Sunitinib (Sutent(R)) is approved by the Food and Drug Administration (FDA) for the treatment of advanced renal cell (kidney) cancer and gastrointestinal stromal tumors. Sunitinib is thought to work by blocking the growth of blood vessels into tumors; reducing the blood supply to tumors can slow their growth and sometimes causes the tumors to shrink. Sirolimus has been approved by the FDA to prevent the body from rejecting organ transplants. Sirolimus is being tested for its effects against cancer because it can slow the growth of some tumors in animal models. Sirolimus is thought to slow cancer growth in these animal models both by direct effects on the tumor cells, and also by blocking production of growth factors that stimulate production of blood vessels. We hope that the combined use of these two drugs will have better anti-cancer effects than either agent alone. This study is designed to find out if different doses of Sirolimus combined with a standard dose of Sutent are safe and well tolerated. Additionally, it is hoped to gain knowledge about the way that Sutent(R) in combination with sirolimus affects the blood vessels produced by cancer. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Tumors | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: 1
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 18 | |||
Original Enrollment ICMJE | 30 | |||
Actual Study Completion Date ICMJE | July 2008 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00402415 | |||
Other Study ID Numbers ICMJE | 0510000723 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Yale University | |||
Study Sponsor ICMJE | Yale University | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Yale University | |||
Verification Date | December 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |