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A Phase II Study of the RAF-Kinase Inhibitor BAY 43-9006 (NSC-724772, IND-69,896) in Combination With Interferon-Alpha 2B in Patients With Advanced Renal Cancer

Phase 2
Not Enrolling
Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

A Phase II Study of the RAF-Kinase Inhibitor BAY 43-9006 (NSC-724772, IND-69,896) in Combination With Interferon-Alpha 2B in Patients With Advanced Renal Cancer


I. To assess response (confirmed complete and partial responses) of patients with advanced
renal cell cancer treated with the combination of BAY-43-9006 and interferon alfa-2b.


I. To assess the probability of treatment failure at 6 months and the median overall
survival of this group of patients.

II. To evaluate the quantitative and qualitative toxicities of this regimen. III. To
investigate in a preliminary manner the association of tumor response with measures of
increased signaling through the Ras-Raf pathway (p-MAPK, p-JNK, p-p38, and p-AKT), with VHL
gene status, and whether changes in levels of IL-6 and tumor markers of hypoxia including
PAI-1, VEGF, and osteopontin correspond with clinical outcomes.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28 and interferon alfa subcutaneously
on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed renal cell carcinoma
which is either metastatic (M1) or unresectable (M0); patients must have a component
of conventional clear cell renal carcinoma; patients with true papillary renal cell
carcinoma, sarcomatoid features without any clear cell component, chromophobe,
oncocytoma, collecting duct tumors and transitional cell carcinoma are NOT eligible

- Patients must have measurable disease; soft tissue disease, which has been radiated
in the 2 months prior to registration, is not assessable as measurable disease;
X-rays, scans, or physical examinations used for tumor measurement must have been
completed within 28 days prior to registration; X-rays, scans or physical
examinations for non-measureable disease must have been completed within 42 days
prior to registration; all disease must be assessed

- Patients with metastatic disease who have a resectable primary tumor and are deemed a
surgical candidate may have undergone resection and have recovered from surgery; at
least 28 days must have elapsed since surgery and patient must have recovered from
any adverse effects of surgery

- Patients must not have received any prior systemic therapy for renal cell carcinoma,
including chemotherapy, interferon, interleukin-2, other biologic response modifiers,
anti-angiogenic therapy, hormonal therapy, or any other experimental systemic
therapy; prior treatment with thyroid medications is allowed

- Patients may have received prior radiation therapy to less than 25% of the bone
marrow; at least 28 days must have elapsed since completion of prior radiation
therapy; patients must have recovered from all associated toxicities at the time of

- Total bilirubin =< institutional upper limit of normal

- SGOT or SGPT =< 2.5 x institutional upper limit of normal

- Serum creatinine =< institutional upper limit of normal or calculated creatinine
clearance >= 60 mL/min for patients with creatinine levels above institutional normal

- Patients who have had a prior nephrectomy must have a serum creatinine =< 2 x
institutional upper limit of normal

- Patients must be offered the opportunity to consent for specimen submission

- Patients must have a Zubrod performance status of 0-1

- Patients with a history of brain metastases or who currently have treated to
untreated brain metastases are not eligible; patients with clinical suspicion of
brain metastases must have a brain CT or MRI negative for metastatic disease obtained
within 56 days prior to registration and must not have any new symptoms since
radiographic evaluation was done

- Any ongoing requirement for systemic corticosteroid therapy is not permitted; topical
and/or inhaled steroids are allowed

- Patients must not be on drugs known to be potent inhibitors of the CYP 3A4 enzyme as
BAY 43-9006 is at least partially metabolized by this enzyme in the liver; the
possible effect that inhibitors of this enzyme may have on the metabolism of BAY
43-9006 is unknown; therefore, patients who are on the following drugs are not
eligible (patients should not take these drugs while receiving protocol treatment):
ketoconazole, itraconazole, ritonavir, products containing grapefruit juice,
cyclosporine, carbamazepine, phenytoin and phenobarbital)

- Patients must be able to take oral medication without crushing, dissolving or chewing

- The effects of BAY 43-9006 on the developing human fetus at the recommended
therapeutic dose are unknown; for this reason and because raf kinase inhibitor agents
as well as other therapeutic agents used in this trial are known to be teratogenic,
patients must not be pregnant or nursing; women/men of reproductive potential must
have agreed to use an effective contraceptive method (hormonal or barrier method of
birth control; abstinence) prior to study entry and for the duration of study
participation; should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
Stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for 5 years

- If Day 28, 42, or 56 falls on a weekend or holiday, the limit may be extended to the
next working day

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal

- At the time of patient registration, the treating institution's name and ID number
must be provided to the Data Operations Center in Seattle in order to ensure that the
current (within 365 days) date of institutional review board approval for this study
has been entered into the database

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response probability

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Christopher Ryan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

  • Clear Cell Renal Cell Carcinoma
  • Recurrent Renal Cell Cancer
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma
  • Carcinoma, Renal Cell



Southwest Oncology Group San Antonio, Texas  78245