Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer

NCT00465179 | Completed Phase 2 Results

• 2 other identifiers: 2006-0437NCI-2010-00583
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The safety of sunitinib malate will also be studied.

Conditions

Renal Cell Cancer; Kidney Cancer

Keywords

Non-Clear Cell Renal Carcinoma; Non-clear cell renal cell cancer; Renal Cell Cancer; Kidney Cancer; Papillary; Chromophobe; Collecting duct carcinoma; CDC; Renal medullary carcinoma; RMC; Sunitinib Malate; Sutent; SU011248

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Response to Treatment

  Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Insufficient shrinkage to qualify for partial response, or insufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years

• Median Progression-Free Survival (PFS)

  Median Progression-Free Survival was calculated as the time from the date of the first treatment to the date of disease progression or date of death, or the last date of the outcome evaluation, whichever came first.

  Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years

Secondary Outcomes (1)

• Median Overall Survival

  Baseline till participant death or end of follow-up period, assessed every 6 weeks for the first two cycles, then every 12 weeks, up to 5 years.

Study Arms (1)

Sunitinib Malate

EXPERIMENTAL

Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off.

Drug: Sunitinib Malate

Interventions

Sunitinib Malate DRUG

50 mg by mouth daily for 4 weeks, then 2 weeks off.

Also known as: Sutent, SU011248

Sunitinib Malate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified. Patients with conventional-type renal cell carcinoma who have \>/= 20% sarcomatoid component in their primary tumor are eligible. Patients who have sarcomatoid features in fine-needle aspiration (FNA) or core biopsy of any metastatic site are eligible.
• Patients must have measurable disease.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Patients must have adequate organ and marrow function within 14 days prior to study entry as defined: Hemoglobin \>/= 9 g/dl, absolute neutrophil count \>/= 1,500/microliter (microL), platelets \>/= 100,000/microL, total bilirubin \</= 1.5 mg/dl, AST(SGOT) and/or ALT (SGPT) \</= 2.5 X institutional uln, except in known hepatic metastasis, wherein may be \</= 5 x uln, serum creatinine \</= 4 X uln (as long as patient does not require dialysis).
• Patients must have recovered from any effects of surgery.
• Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a normal plasma beta human chorionic gonadotropin (betaHCG) within 24 hours prior to enrolling in the study.
• Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study (barrier method, hormonal methods, etc.).
• Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged (by the treating physician) able to fully understand the investigational nature of the study and the risks associated with the therapy.
• Patients with brain metastases may participate in this trial.
• Patients who have had up to two prior systemic therapies are eligible to participate in this trial but they should not have had prior Multi-Tyrosine Kinase Inhibitors such as sorafenib or sunitinib malate.

You may not qualify if:

• No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 2 years.
• Pregnant or lactating women are excluded.
• Patients must not be scheduled to receive any experimental drug for MRCC while on study. Patients are permitted to be on concomitant bisphosphonates. Patients are permitted to receive hematopoietic growth factors according to American Society of Clinical Oncology (ASCO) guidelines.
• Patients must not have had prior radiotherapy to areas of measurable disease, unless they have clearly progressive disease in this site, or there is measurable disease outside the area of prior radiation. Radiotherapy, if needed for palliation, must have been completed at least 2 weeks prior to enrollment on this study.
• Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of sunitinib malate or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
• Concomitant treatment with drugs with dysrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, and indapamide) is not recommended.
• Patients unwilling to participate or unable to comply with the protocol for the duration of the study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Nizar M Tannir, MD, Professor, Genitourinary Medical Oncology
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Nizar M. Tannir, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 24, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 7, 2016
• Results First Posted: May 4, 2016

Record last verified: 2016-05

Locations

US (1)