A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma
NCT00480935
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- Histologically confirmed renal cell carcinoma with a component of clear (conventional) cell histology, which has been assessed with biopsy at screening.
- Locally confined tumour ≤ 7 cm
- Has not undergone nephrectomy and is a candidate for surgical treatment of renal cell carcinoma
- Male or female, 18 years of age or older
- ECOG performance status 0 or 1
- Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) less than or equal to 2.5 x central laboratory upper limit of normal (CL-ULN), or AST and ALT less than or equal to 5 x CL ULN if liver function abnormalities are due to underlying malignancy
- Total serum bilirubin less than or equal to 1.5 x CL-ULN
- Absolute neutrophil count (ANC) greater than or equal to 1500/mL
- Platelets greater than or equal to 100,000/mL
- Hemoglobin greater than or equal to 9.0 g/dL
- Serum calcium less than or equal to 12.0 mg/dL
- Serum creatinine less than or equal to 1.5 x CL-ULN
- Prothrombin time (PT) less than or equal to 1.5 x CL-ULN
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- Prior therapy of any kind for RCC (including nephrectomy, immunotherapy, chemotherapy,
radiation, hormonal, or investigational therapy)
- Abnormal ECG- including long QT/QTc interval, AV block or arrythmia
- Tumour associated with local extension into adjacent tissues
- Tumour associated with renal/vena caval thrombus
- Tumour associated with lymphadenopathy (lymph node > 1 cm)
- Evidence of rapidly progressive disease or other factors requiring surgery to take
place before the 12 weeks scheduled for neoadjuvant treatment
- Major surgery within 4 weeks of commencing study treatment
- Any toxicity with a NCI CTCAE grade 3 or 4
- Diagnosis of any second malignancy within the last 5 years, except for adequately
treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer
- Evidence of metastatic renal cell carcinoma
- Any of the following within the 12 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
the normal range with medication
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness
- Current treatment on another clinical trial
- Pregnancy or breastfeeding
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma | |||
| Official Title ICMJE | A Phase II, Single Arm, Prospective Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma | |||
| Brief Summary | Study Hypothesis: Patients with local renal cell carcinoma who are treated neoadjuvantly with Sutent may show a radiologic response to the study drug (Sutent). The study is looking at the neoadjuvant (pre-surgery) administration of Sutent in patients with localized kidney cancer. The purpose of this research is also to evaluate both the safety and effectiveness of Sutent in this patient population. | |||
| Detailed Description | Sutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 1 week rest period. The dosage may change during the cycle due to possible drug toxicities. The nephrectomy will then take place following a one-week washout period. After surgery, patients will have follow-up visits at 6 weeks and 3 months. Patients will be followed for 3 years after completions to assess late toxicities, time to progression and progression-free survival. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Renal Cell Carcinoma | |||
| Intervention ICMJE | Drug: Sunitinib Malate (Sutent)
Sutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 1 week washout period. The dosage may change during the cycle due to possible drug toxicities. The nephrectomy will then take place following a one-week washout period. Other Name: Sutent | |||
| Study Arms ICMJE | Experimental: Sunitinib Malate (Sutent)
Sutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 2 week rest period to comprise a complete cycle of 6 weeks. Patients will then continue on Sutent for another cycle of 4 consecutive weeks Intervention: Drug: Sunitinib Malate (Sutent) | |||
| Publications * |
| |||
* 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 | 3 | |||
| Original Estimated Enrollment ICMJE | 30 | |||
| Actual Study Completion Date ICMJE | October 2011 | |||
| Actual Primary Completion Date | October 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 | Canada | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00480935 | |||
| Other Study ID Numbers ICMJE | 07-0017-C | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | University Health Network, Toronto | |||
| Study Sponsor ICMJE | University Health Network, Toronto | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | University Health Network, Toronto | |||
| Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||