Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer

NCT00496756 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 0081-06-FBP30CA036727
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects and how well sorafenib works in treating patients with metastatic or unresectable kidney cancer.

Conditions

Kidney Cancer

Keywords

clear cell renal cell carcinoma; stage III renal cell cancer; stage IV renal cell cancer; recurrent renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity of Intrapatient Dose Escalation of Sorafenib Tosylate

  To evaluate the toxicity of dose escalating sorafenib, an estimation of the percentage of patients who are unable to tolerate those escalated doses will be made. Patients will be dose escalated every 4 weeks until a maximum dose of 800 mg BID is reached.

  Study completion

Secondary Outcomes (1)

• Response Rate

  from the start of the treatment until disease progression/recurrence

Study Arms (1)

Sorafenib

OTHER

The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in following section. Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d. A treatment cycle will be 4 weeks. Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol.

Drug: Sorafenib

Interventions

Sorafenib DRUG

initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily.Intrapatient dose escalation will occur providing no dose limiting toxicity (Grade 3 or 4) is observed. Dose level 2 600mg. Dose level 2 800mg

Also known as: Nexavar

Sorafenib

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed renal cell carcinoma (RCC)
• Must have a component of conventional clear cell RCC
• Predominant clear cell component ≥ 75%
• Metastatic or unresectable disease (Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan or MRI)
• Measurable or nonmeasurable disease, includes any of the following:
• Small lesions, longest diameter \< 20 mm by conventional techniques or \< 10 mm by spiral CT scan
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Lymphangitis cutis/pulmonitis
• Abdominal masses that are not confirmed and followed by imaging techniques
• Cystic lesions
• Irradiated lesions, unless progression is documented after radiotherapy
• Paraffin RCC tissue blocks or unstained slides must be obtained for future chemistry staining of VEGF

You may not qualify if:

• Patients with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors, or transitional cell carcinoma are not eligible
• No evidence of CNS metastases
• No imaging (MRI or CT scan of the brain) abnormality indicative of CNS metastases within past 42 days
• Not pregnant or nursing (negative pregnancy test)
• No ongoing hemoptysis
• No cerebrovascular accident within the past 12 months
• No peripheral vascular disease with claudication while walking less than 1 block
• No history of clinically significant bleeding
• No deep venous thrombosis or pulmonary embolus within the past year
• No significant cardiovascular disease, defined as NYHA class II-IV congestive heart failure, angina pectoris requiring nitrate therapy, or myocardial infarction within the past 6 months
• No uncontrolled hypertension, defined as systolic BP \> 160 mm Hg and/or diastolic BP \> 90 mm Hg while on medication
• No preexisting thyroid abnormality whose thyroid function cannot be maintained in the normal range by medication
• No uncontrolled psychiatric disorder
• No delayed healing of wounds, ulcers, and/or bone fractures
• No currently active second malignancy except nonmelanoma skin cancer (patients are not considered to have a 'currently active' malignancy if they have completed anticancer therapy and are considered by their physician to be at less than 30% risk of relapse)

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator
• Bayer: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Ralph Hauke, MD
• Organization: University of Nebraska Medical Center

rhauke@nebraskacancer.com

402-354-8124

Study Officials

• Ralph Hauke, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: July 3, 2007
• First Posted: July 4, 2007
• Study Start: March 1, 2007
• Primary Completion: October 31, 2009
• Study Completion: April 25, 2014
• Last Updated: October 26, 2023
• Results First Posted: February 15, 2019

Record last verified: 2023-10

Locations

US (1)