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| ID | Type | Description | Link |
|---|---|---|---|
| UHN REB 07-0357-C |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib and palliative radiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | Dose level 1: sorafenib 200mg PO OD on Days 1-84 Dose level 2: sorafenib 400mg PO OD on Days 1-84 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in pain from index lesion 4 weeks following the completion of radiotherapy, assessed using Brief Pain Inventory. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Eligibility Criteria
Eligible patients must have histologically or cytologically confirmed metastatic RCC that is judged to be incurable with standard therapy.
Patients must have at least one radiographically-evident symptomatic (> 2/10 on the Brief Pain Inventory) bone metastasis that is amenable to palliative radiation. Multiple symptomatic bone metastases may be irradiated at the same time. However, if more than one symptomatic bone metastasis is identified, one will be chosen as the index lesion for reporting purposes.
No planned change in analgesic medications.
No planned increase in regular analgesic medications.
No prior surgery to the index lesion, although previous surgery for other metastatic disease is permissible if > 4 weeks prior to study registration.
Patients may have had up to two previous lines of systemic treatment for metastatic RCC, including prior treatment with sorafenib or another similar multi-targeted tyrosine kinase inhibitor, if completed >4 weeks prior to study registration.
Patients may not have had previous radiotherapy to the index lesion. Patients may have had previous radiotherapy to other metastases if completed > 4 weeks prior to study registration. Patients must have recovered from the acute side effects of radiotherapy prior to study registration.
Age >18 years.
Life expectancy of greater than 3 months.
ECOG performance status < 2 (Karnofsky > 60).
Patients must have normal organ and marrow function as defined below:
i. Absolute neutrophil count >1.5 x109 /L ii. Platelet count >75 x109 /L iii. Total bilirubin < 1.5 x ULN iv. AST (SGOT) / ALT (SGPT) < 2.5 × institutional ULN or < 5 x institutional ULN if liver metastases v. Creatinine <1.7 x ULN or vi. Creatinine clearance > 50 mL/min/1.73 m2 vii. International Normalized Ratio (INR) < 1.5 viii. Hemoglobin value Hb > 80 g/L ix. Serum phosphate level > 0.80 mmol/L x. Serum lipase, normal values (range of 5-208 U/L) xi. Serum amylase, normal values (range 30-110 U/L)
Ability to understand and the willingness to sign a written informed consent document.
The effects of sorafenib on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation. Effective methods of birth control would include a barrier method (e.g. condoms, diaphragm) combined with spermicide, or an intrauterine device (IUD). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hosptial | Toronto | Ontario | M5G2M9 | Canada |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| external beam radiotherapy | Radiation | 3000cGy in 10 fractions |
|
| 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 |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |