MDACC Study Summary 2007-0223

Study Summary
No. 2007-0223:.......Fallopian Tube; Ovary; Peritoneum......Anil Sood......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2007-0223

Study Title:	Pilot Trial of Intraperitoneal Paclitaxel and Carboplatin with IV Avastin Therapy in Treatment of Women with Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin

Physician

New Patient Referral



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

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

Phone:	713-792-7310 Contact us about clinical trials

General Information



Disease Group:	Fallopian Tube Ovary Peritoneum	Supported By:	NCI SPORE (supplemental funding) and Genentech Inc. (Avastin)

Phase of Study:	N/A	Return Visit:	18 weeks (weekly for 6 cycles of 3 weeks each)

Treatment Agents:	Avastin Carboplatin Paclitaxel	Home Care:	None

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to learn about the safety and tolerability of paclitaxel and carboplatin when given in combination with Avastin to patients with ovarian, primary peritoneal, or fallopian tube cancer.

Study Objectives / Outcomes

Primary study goals:

To investigate the safety and tolerability of carboplatin and paclitaxel administered IP in combination with IV Avastin

To determine if Avastin influences the pharmacokinetics of IP administered chemotherapeutic agents

Secondary study goals:

To determine the systemic exposure to paclitaxel and carboplatin during initial and late cycles of IP dosing.

To collect overall survival (OS) and progression-free survival (PFS)

To determine changes in IP VEGF levels

To determine site of first recurrence

Information on CA-125 response and clinical response will be descriptive as secondary goals of this study

Exploratory goal:

To estimate proportion of patients completing entire course of treatment

Study Status Information



Study Activation / Registration Date:	02/25/2008

IRB Review and Approval Date:	02/25/2008

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	46

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) Histologically confirmed epithelial carcinoma of mullerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma will be allowed. All histologic subtypes are eligible.

2) Stage III or IV disease. Stage IV disease by virtue of pleural effusions is allowed but stage IV disease with visceral metastases e.g. lung, liver or abdominal wall is NOT ELIGIBLE. Please discuss any eligibility concerns directly with the P.I., Dr. Carolyn Krasner.

3) Patient must have undergone surgical staging and debulking with optimal (less than 1cm) cytoreduction.

4) No significant intra-abdominal adhesions or other contraindication to IP port placement.

5) Patients must give written informed consent.

6) Patient must be age 18 years or older.

7) Adequate bone marrow function with an ANC greater that 2,500 and Platelets greater than 100,000 cubic millimeters.

8) No proteinuria or less than +1; if greater, 24-hour urine collection must be performed to document less than or equal to 1gm/24 hours of protein.

9) ECOG performance status less than or equal to 1.

Exclusion Criteria:

1) Visible disease onpost-operative imaging (recognizing the limitations of postoperative CT scans due to postoperative changes there should be unequivocal CT evidence of residual disease greater than 1cm)

2) ECOG performance status greater than or equal to 2

3) Previous chemotherapy for the disease under study

4) Suboptimal (greater than 1 cm residual disease) cytoreduction

5) Creatinine greater than 1.5 mg/dL

6) SGOT greater than 2 x ULN, bilirubin greater than 1.5 x ULN

7) Colostomy or ileostomy

8) Concurrent invasive malignancy. (Patients with concurrent superficial endometrial carcinoma are eligible if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium.)

9) Known hypersensitivity to E.coli derived products or to any component of Avastin

10) Active psychiatric or mental illness that makes informed consent or careful clinical follow-up unlikely

11) History of myocardial infarction within 6 months

12) History of stroke or transient ischemia attack within 6 months

13) Inadequately controlled hypertension greater than 140/90 mm Hg on antihypertensive medication(s)

14) Any prior history of hypertensive crisis or hypertensive encephalopathy

15) Clinically significant peripheral vascular disease

16) Significant vascular disease (e.g. aortic aneurysm, aortic dissection)

17) Unstable angina

18) New York Heart Association (NYHA) grade II or greater congestive heart failure

19) Evidence of coagulopathy or bleeding diathesis

20) Known central nervous system disease or brain metastases

21) Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 28 (first dose of Avastin), anticipation of need for major surgical procedure during the course of the study

22) Minor surgical procedures such as fine needle aspirations or core biopsies or laparoscopy for IP catheter placement within 7 days prior to cycle 2 day 8

23) Open wound, ulcer, or bone fracture

24) History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess; current signs and sypmptoms of bowel obstruction; current dependency on IV hydration or TPN

25) Pregnant (positive pregnancy test) or lactating

Links

Registration Number: NCT00652119
Study Information on Clinical Trials Registry (clinicaltrials.gov)