MDACC Study Summary 2006-1068 (Archived)

Study Summary
No. 2006-1068:.......Advanced Cancers; Solid Tumors......Apostolia M. Tsimberidou......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2006-1068

Study Title:	Phase I trial of intraperitoneal oxaliplatin and paclitaxel plus intravenous paclitaxel and bevacizumab in the treatment of advanced peritoneal carcinomatosis

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 Solid Tumors	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	The patient will have office visit once every 21 days or sooner as needed, and be admitted for treatment as mentioned above.

Treatment Agents:	Bevacizumab Oxaliplatin Paclitaxel	Home Care:	The initial or loading doses of bevacizumab and paclitaxel will be given in the clinic. Subsequent doses may be given at home.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	During each cycle, the patient will be admitted for 3 days (d1 to d3) to have intravenous bevacizumab, continuous intravenous infusion of paclitaxel and intraperitoneal oxaliplatin; and then for 2 days (d8 to d9) to have intraperitoneal paclitaxel.


Description/ Intervention:	The goal of this clinical research is to learn acceptable dosages of paclitaxel, oxaliplatin, and Avastin (bevacizumab) that can be given in combination to patients with advanced peritoneal carcinomatosis. The safety of this drug combination will also be studied.

Study Objectives / Outcomes

1. To establish acceptable dosages of paclitaxel, oxaliplatin and bevacizumab in a regimen of intravenous bevacizumab followed by continuous intravenous infusion of paclitaxel on day 1, intraperitoneal oxaliplatin on day 2, and intraperitoneal paclitaxel on day 8 once every 3 weeks in patients with advanced peritoneal carcinomatosis.

2. To assess toxicity profile.

3. To assess clinical responses.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	06/22/2007

Study Type:	Phase I

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 must have advanced peritoneal carcinomatosis: they have either a disease where there is no established standard of care therapy or have failed one or more prior therapy. These include, but not limited to, recurrent epithelial ovarian cancer, advanced endometrial cancer, advanced gastric cancer, advanced colorectal cancer, and advanced primary peritoneal mesothelioma without significant chest involvement. Previous intraperitoneal therapy with different agents is allowed as long as their diseases have progressed.

2) Patients must have ECOG performance status < or = 2 (0-2).

3) Patients must have normal organ and marrow function as defined below: Absolute neutrophil count > or = 1,500/mcL Platelets > or = 100,000/mcL Total bilirubin < or = 2.0 and ALT <2.5 X the institutional upper limit of normal; Creatinine < or = 2.0 mg/dL or creatinine clearance > or = 40mL/min/1.73m2.

4) Patients must be able to understand and the willingness to sign an IRB-approved written informed consent document.

5) Patients must have evidence of peritoneal carcinomatosis that is evaluable by CT or MRI.

6) In the clinical judgment of the investigator, patients must have adequate potential intraperitoneal fluid distribution with no gross fluid loculations and adhesions that would significantly affect intraperitoneal drug distribution. This determination may be made based on documented clinical, imaging or laboratory assessment.

7) Patients must have PT/PTT within 1.2 x the institutional upper limit of normal or < 3 x the institutional upper limit of normal on anticoagulants.

8) Patients must have resting blood pressure no greater than 140 mmHg(systolic) or 90 mmHg (diastolic) for eligibility. Initiation or adjustment of blood pressure medication is permitted prior to study entry.

Exclusion Criteria:

1) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, symptomatic cardiac arrhythmia, active bleeding, active thrombosis, or psychiatric illness/social situations that would limit compliance with study requirements.

2) History of allergic reactions to the study drugs or their analogs.

3) Failure to recover from any prior surgery within 4 weeks of study entry.

4) Pregnant or lactating. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry, for the duration of study participation and for at least 3 months after the last treatment.

5) Any treatment specific for tumor control within 3 weeks of study drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 wks for nitrosoureas or mitomycin C), or within 5 half-lives for target agents with half lives and pharmacodynamic effects lasting less than 5 days (that include but are not limited to erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents); or failure to recover from the toxic effect of any therapy prior to study entry.

6) Serious non-healing wound, ulcer, bone fracture (including abdominal fistula, gastrointerestinal perforation or intra-abdominal abscess), or history of bleeding diathesis.

7) History of radiotherapy to the abdominal and pelvic regions or history of multiple abdominal surgeries that contraindicates this protocol therapy.

8) Urine dipstick for proteinuria >/= 2+ (patients discovered to have >/= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate </= 1g of protein in 24 hours to be eligible).

9) Grade 2 or greater neuropathy, and history of brain or leptomeningeal metastases that significantly increase risks of intracranial bleeding.

Links

Registration Number: NCT00491855
Study Information on Clinical Trials Registry (clinicaltrials.gov)