MDACC Study Summary 2004-0516 (Archived)

Study Summary
No. 2004-0516:.......Kidney......Eric Jonasch......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	2004-0516

Study Title:	A Phase II Neoadjuvant Clinical Trial to Evaluate the Efficacy of BAY43-9006 (sorafenib) in Metastatic Renal Cell Carcinoma

Physician

New Patient Referral



Name:	Eric Jonasch	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Genitourinary Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2830 Contact us about clinical trials

General Information



Disease Group:	Kidney	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Patients visit MDACC every 2-weeks during first 4-week course before the surgery. And every 2 weeks until first restaging. Thereafter, patients will visit MDACC every 4 weeks.

Treatment Agents:	BAY 43-9006	Home Care:	The twice a day BAY 43-9006 oral pill.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if BAY43-9006 can control metastatic renal cell carcinoma. The safety of this drug will also be studied.

Study Objectives / Outcomes

Primary:
1. Efficacy of BAY 43-9006 by evaluating response rate.
2. Toxicities of BAY 43-9006 in metastatic RCC.
3. Intraoperative and peri/postoperative safety of BAY 43-9006.

Secondary:

Clinical:

1. Time to progression
2. Duration of response
3. Overall survival

Preclinical:

1. Tissue expression of VEGFR-2/phospho-VEGFR-2, PDGFR/phospho-PDGFR, FGFR/phospho-FGFR, ERK/phospho-ERK, RAF-1/phospho-RAF-1, p38/phospho-p38, Akt/phospho-Akt, , P27, Ki67, TGF-a, and TUNEL pre- and post- therapy (optional studies).
2. Oligonucleotide microarray analysis of tissue pre- and post-therapy (optional studies).

Study Status Information



Study Activation / Registration Date:	01/11/2006

IRB Review and Approval Date:	12/15/2004

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with histologically or cytologically confirmed metastatic clear cell RCC who are eligible for cytoreductive nephrectomy as agreed upon by Medical Oncology and Urology team members. Patients with metastatic disease eligible for cytoreductive nephrectomy should have the following characteristics: resectable primary tumor (no gross adjacent organ invasion, no or minimal abdominal lymphadenopathy, no or minimal inferior vena caval involvement), bulk of metastatic disease within the primary tumor, absence of multiple liver metastases, no more than 2 organ sites involved with metastases.

2) Patients must have measurable disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures >/= 20 mm with conventional techniques or >/= 10 mm with spiral CT scan.

3) Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of BAY 43-9006 in patients < 18 years of age, children are excluded from this study.

4) ECOG performance status </= 1.

5) Pts must have adequate organ & marrow function within 14 days as defined: (1) absolute neutrophil count >/= 1,500/uL; (2) platelets >/= 100,000/uL; (3) Hgb >9.0 g/dL (may be transfused or receive epoetin alfa [e.g., Epogen�] to maintain or exceed this level); (4) total bilirubin </= 2.0 mg/dl; (5) albumin >3.0 g/dL; (6) serum creatinine </= 2.0 mg/dl; (7) AST(SGOT) &/or ALT (SGPT) </= 2.5 X institutional upper limit of normal for subj. w/o evidence of liver metastases; (8) AST(SGOT) &/or ALT (SGPT) </= 5 X institutional upper limit of normal for subjects w/ documented liver metastases

6) Female patients of childbearing potential must have a normal plasma beta human chorionic gonadotropin (bHCG) within 24 hours prior to enrolling in the study due to the possible teratogenic effect. However, patients will be eligible if their BHCG elevation is due to tumor production.

7) Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study.

8) 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 able to fully understand the investigational nature of the study and the risks associated with the therapy. The only approved consent is attached to this protocol.

9) Patients must have ability to comply with study and/or follow-up procedures.

10) Prior biopsy material (blocks or unstained slides) must be available for comparison purposes.

Exclusion Criteria:

1) 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 5 years.

2) Patients must not have received any systemic anticancer therapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

3) Patients must not be scheduled to receive another experimental drug while on this study. Patients are permitted to be on concomitant bisphosphonates.

4) Patients who are incapable of swallowing pills are excluded from the study.

5) Patients must not have a primary brain tumor, any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, or history of stroke.

6) Patients must not have active acute infections that could be worsened by anticancer therapy or interfere with this study.

7) Patients must not have clinically significant cardiovascular disease, recent myocardial infarction(i.e. last 6 months), (unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia requiring medication, or peripheral vascular disease (Grade II or greater)

8) 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 an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.

9) Patients with uncontrolled hypertension > 140/90 are excluded from the study.

10) Patients must not have any history of bleeding diathesis. Patients must not be on therapeutic anticoagulation. Prophylactic anticoagulation (i.e. low dose coumadin) of venous or arterial access devices is allowed provided that the requirements for PT, INR or PTT are met.

11) Pregnant women are excluded from this study because BAY 43-9006 is a kinase inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BAY 43-9006, breastfeeding should be discontinued if the mother is treated with BAY 43-9006.

12) 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 BAY 43-9006. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.

Links

Registration Number: NCT00126659
Study Information on Clinical Trials Registry (clinicaltrials.gov)