MDACC Study Summary 2006-0638

Study Summary
No. 2006-0638:.......Advanced Cancers......Gerald Falchook......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2006-0638

Study Title:	A PHASE 1 STUDY OF BEVACIZUMAB IN COMBINATION WITH 1) SUNITINIB, 2) SORAFENIB, 3) ERLOTINIB AND CETUXIMAB, 4) TRASTUZUMAB AND LAPATINIB

Physician

New Patient Referral



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

Dept:	Investigational Cancer Therapeutics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-1930 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Patients are seen and evaluated in the phase I clinic weekly during cycle 1, and at the end of each cycle thereafter. Other visits include the IV treatments specified by the study and optional research correlative studies (blood draws, DCE-MRI).

Treatment Agents:	Bevacizumab Cetuximab Erlotinib Lapatinib Sorafenib Sunitinib Malate Trastuzumab	Home Care:	Patient will be given oral medication (sorafenib, sunitinib, erlotinib, lapatinib) per treatment protocol to take at home.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

Primary objective:

To determine the maximum tolerated dose (MTD) and dose-limiting

toxicities (DLT) of bevacizumab when used in combinations with:

sunitinib
sorafenib
erlotinib and cetuximab
trastuzumab and lapatinib

Secondary objectives:

Preliminary descriptive assessment of anti-tumor efficacy of each

combination.

Assessment of anti-angiogenesis correlates.

Study Status Information



Study Activation / Registration Date:	10/10/2007

IRB Review and Approval Date:	10/10/2007

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	354

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 advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.

2) Patients must be three weeks from prior cytotoxic therapy; if they have recovered their blood counts to eligibility levels sooner and have no mucositis or other acute toxicities, they may be treated earlier but no sooner than two weeks after their last chemotherapy. Patients must be two weeks or five half lives from biologic therapy, whichever is shorter.

3) ECOG performance status </= 2 (Karnofsky >/= 60%).

4) Patients must have normal organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/=75,000/mL; creatinine </= 3 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 3 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT(SGPT) </= 5 X ULN. Exception for the bevacizumab + erlotinib + cetuximab arm and the bevacizumab + trastuzumab + lapatinib arm: no minimum absolute neutrophil count or platelet count.

5) The effects of bevacizumab on the developing human fetus are unknown. Angiogenesis is of critical importance to fetal development, and bevacizumab is likely to have adverse consequences in terms of fetal development. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.

6) Ability to understand and the willingness to sign a written informed consent document.

7) Life expectancy of at least 3 months.

8) Patients with a prior DVT/PE are eligible for treatment if they are receiving or have finished receiving appropriate anticoagulation therapy.

Exclusion Criteria:

1) Patients with hemoptysis within 28 days prior to entering the study.

2) Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.

3) Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).

4) Patients with clinically significant cardiovascular disease: history of CVA within 6 months, myocardial infarction or unstable angina within 6 months, or unstable angina pectoris.

5) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.

6) Pregnant or lactating women.

7) History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.

8) (For patients on the sunitinib treatment arm and the trastuzumab/lapatinib treatment arm only) Left ventricular ejection fraction of less than 50% unless the patient is receiving an angiotensin-converting enzyme (ACE) inhibitor / angiotensin receptor blocker (ARB) and a beta-blocker.

9) (For sorafenib treatment arm only) Hypersensitivity to sorafenib or any component of the formulation.

10) (For erlotinib and cetuximab treatment arm only) History of hypersensitivity to erlotinib or any component of the formulation.

11) (For erlotinib and cetuximab treatment arm only) History of hypersensitivity to cetuximab, murine products, or any component of the formulation.

12) (For trastuzumab and lapatinib treatment arm only) History of hypersensitivity to trastuzumab, Chinese hamster ovary cell proteins, or any component of the formulation.

13) (For trastuzumab and lapatinib treatment arm only) History of hypersensitivity to lapatinib or any component of the formulation.

14) Patients with clinically significant gastrointestinal bleeding within 28 days prior to entering the study.

15) Patients with hemorrhagic brain metastases.

16) Patients with prior abdominal surgery within 30 days prior to entering the study.

17) (For patients on the sunitinib treatment arm and the trastuzumab/lapatinib treatment arm only) Left ventricular ejection fraction of less than 50%, unless the patient is receiving an angiotensin-converting enzyme (ACE) inhibitor / angiotensin receptor blocker (ARB) and a beta-blocker.

18) (For patients on the sunitinib treatment arm and the trastuzumab/lapatinib treatment arm only) QTc prolongation, defined as greater than 440 mimlliseconds for males, and greater than 460 mmilliseconds for females.

Links

Registration Number: NCT00543504
Study Information on Clinical Trials Registry (clinicaltrials.gov)