MDACC Study Summary 2009-0410

Study Summary
No. 2009-0410:.......Advanced Cancers......Apostolia M. Tsimberidou......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2009-0410

Study Title:	A multi-arm Phase I trial of hepatic arterial infusion of irinotecan with 1) systemic bevacizumab 2) systemic bevacizumab and oxaliplatin 3) systemic bevacizumab and cetuximab in patients with advanced cancers metastatic to the liver

Physician

New Patient Referral



Name:	Apostolia M. Tsimberidou	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:	713-792-4259 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Weekly during the 1st cycle & thereafter every 4 weeks or earlier as necessary for a doctor/midlevel visit. The initial or loading doses of bevacizumab, oxaliplatin, and/or cetuximab will be given in the clinic. Subsequent doses may be given at home.

Treatment Agents:	Bevacizumab Cetuximab Irinotecan Oxaliplatin	Home Care:	The initial or loading doses of bevacizumab, oxaliplatin, and/or cetuximab will be given in the clinic. Subsequent doses may be given at home.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	4-5 days every 28 days


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

Primary objectives-
To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of continuous hepatic arterial infusion of irinotecan in patients with advanced cancers metastatic to the liver when used in combination with:
A. Systemic bevacizumab
B. Systemic bevacizumab and oxaliplatin
C. Systemic bevacizumab and cetuximab

Secondary objectives-
1. Preliminary descriptive assessment of anti-tumor efficacy of each combination.
2. Assessment of biological and anti-angiogenesis correlates.

Study Status Information



Study Activation / Registration Date:	09/17/2009

IRB Review and Approval Date:	09/17/2009

Study Type:	Phase I

Recruitment Status:	Open

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 confirmed metastatic advanced cancers with liver involvement.

2) Patients should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three months, unless the drugs included in the regimen are part of their standard treatment.

3) Irinotecan will be dosed regardless of creatinine clearance. For oxaliplatin, serum creatinine </= 2.5 times the upper limit of normal or creatinine clearance >/= 40 is required.

4) Hepatic function: T. Bilirubin </= 3 mg/dl, ALT </= 5X ULN.

5) Adequate bone marrow function (ANC >/=1000 cells/uL; PLT >/= 100,000 cells/uL).

6) Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study. Six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosurea). Five half-lives will be required for biologic/targeted therapies with short (<24 hour) half-lives and pharmacodynamic effects. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.

7) All females in childbearing age MUST have a negative serum or urine pregnancy test unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity). Patients should not become pregnant or breast feed while on this study. Sexually active patients should use effective birth control.

8) ECOG Performance status </= 2.

Exclusion Criteria:

1) Pregnant females.

2) Patients with colorectal cancer and K-RAS mutation will be excluded from the cetuximab arm.

3) History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.

4) Invasive procedures defined as follows: a. Major surgical procedure within 28 days prior to Day 1 therapy. b. Anticipation of need for major surgical procedures during the course of the study.

5) Patients receiving any other investigational agents.

6) Patients with bleeding diathesis (clinical bleeding, prothrombin time >/= 1.5 X upper institutional normal value, INR >/=1.5, activated partial thromboplastin time aPTT >/= 1.5 X upper institutional normal value, NOT due to anticoagulation therapy), active gastric or duodenal ulcer.

7) Patients with history of bleeding CNS metastasis will be excluded from the trial.

8) Hypersensitivity to any of the drugs in a particular treatment arm.

9) Inability to complete informed consent process and adhere to protocol treatment plan and follow up requirements.

10) History of heparin-induced thrombocytopenia.

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

Links

Registration Number: NCT00980239
Study Information on Clinical Trials Registry (clinicaltrials.gov)