Study of Sorafenib and Palliative Radiotherapy in Kidney Cancer That Spreads to the Bone

NCT00609934 | Completed Phase 1 DMC

• 2 other identifiers: DDPDRO-004UHN REB 07-0357-C
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the use of a new anti-angiogenic drug called sorafenib, in combination with radiotherapy, for renal cell cancer that has spread to the bone and is causing significant pain. The study will find a safe dose of sorafenib for this combination study treatment, look at side effects, and test if the study treatment is effective in controlling the pain experienced from this type of renal cell cancer. . There will be two parts or phases to this study The purpose of the first phase is to find the highest dose of sorafenib that can be given safely to patients, when combined with radiotherapy. We will also see what kind of effects the study treatment has on you and your cancer. Participants in this phase will receive a dose of sorafenib that has shown to be well-tolerated in humans. If the side effects are tolerable for this dose of sorafenib when combined with radiotherapy, new patients will be asked to join the study and will receive a dose of sorafenib higher than the last study participant. In the second phase, new study participants will receive the dose of sorafenib that was determined to be safe in the first phase. Side effects will continue to be looked at and the effectiveness on controlling pain symptoms from this type of cancer, will also be looked at.

Conditions

Renal Cell Carcinoma

Keywords

renal cell carcinoma; kidney cancer; bone metastases; RCC; bone pain; palliative radiotherapy; sorafenib; radiation; renal cell

Outcome Measures

Primary Outcomes (1)

• Reduction in pain from index lesion 4 weeks following the completion of radiotherapy, assessed using Brief Pain Inventory.

  7 weeks

Secondary Outcomes (5)

• reduction in pain in index lesion at study termination assessed using Brief Pain Inventory

  12 weeks

• acute toxicity of palliative radiotherapy and sorafenib together

  12 weeks

• acute toxicity of sorafenib alone

  1 week

• biologic response of the index lesion to radiotherapy and sorafenib assessed using FDG-PET-CT

  7 weeks

• disease-free survival

  greater than 3 months

Study Arms (1)

Sorafenib and palliative radiotherapy

EXPERIMENTAL

Drug: Sorafenib; Radiation: external beam radiotherapy

Interventions

Sorafenib DRUG

Dose level 1: sorafenib 200mg PO OD on Days 1-84 Dose level 2: sorafenib 400mg PO OD on Days 1-84

Also known as: BAY 43-9006, NSC 724772

Sorafenib and palliative radiotherapy

external beam radiotherapy RADIATION

3000cGy in 10 fractions

Sorafenib and palliative radiotherapy

Eligibility Criteria

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

You may not qualify if:

• Serious medical condition that might be aggravated by treatment, including but not limited to: myocardial infarction within 6 months, congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders, serious infections, active peptic ulcer disease, active liver disease, or cerebrovascular disease with previous stroke.
• Patients may not be receiving any other investigational agent concurrently or within 4 weeks of study registration. Patients receiving other molecularly-targeted treatments for RCC off of study, including inhibitors of angiogenesis or mTOR, will be eligible for this study after a 1 week wash-out period.
• Patients with clinical or radiological evidence of spinal cord compression are ineligible.
• Patients who are at high risk of pathologic fracture and appropriate for surgical intervention are ineligible.
• Patients who are planned for palliative surgical intervention to the index lesion or adjacent bone are ineligible.
• Pregnant or lactating women are excluded from this study because the safety of sorafenib has not been established in these circumstances.
• 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 sorafenib.
• Patients with other active malignancies other than non-melanoma skin cancer are excluded.
• Patients who have had significant surgical procedures requiring a general anaesthetic (for example, open laparotomy or thoracotomy) within the past month
• Patients who possess significant unhealed wounds or ulcers
• Patients with any bleeding or clotting disorder
• Patient taking greater than 325mg of aspirin per day
• Patients with diabetes mellitus will be ineligible for the PET-CT components of the study, but will remain eligible to receive sorafenib.
• Patients who are currently taking rifampin, phenytoin, carbamazepine, Phenobarbital, dexamethasone and St. John's Wort.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hosptial

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Sorafenib

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)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 7, 2008
• Study Start: December 1, 2007
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 23, 2015

Record last verified: 2015-07

Locations

CA (1)