MDACC Study Summary 2006-0405

Study Summary
No. 2006-0405:.......Fallopian Tube; Ovary; Peritoneum......Robert Coleman......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2006-0405

Study Title:	A Phase I Dose Escalation Study of ABI-007 with Carboplatin as First-Line Therapy in Patients with Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

Physician

New Patient Referral



Name:	Robert Coleman	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:	713-745-3357 Contact us about clinical trials

General Information



Disease Group:	Fallopian Tube Ovary Peritoneum	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Chemotherapy may be administered in an outpatient setting. Patients will be assigned to receive treatment either weekly for 2 weeks (days 1 and 8 of a 21-day cycle), or once every 3 weeks.

Treatment Agents:	Abraxane Carboplatin	Home Care:	n/a

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to find the highest dose of ABI-007 (Abraxaneā) that can be safely combined with a standard dose of carboplatin (Paraplatinā) and given to patients with ovarian, primary peritoneal, or fallopian tube cancer.

Study Objectives / Outcomes

The primary objective of this study is to determine the MTD and dose-limiting toxicities (DLTs) of weekly and every-3-weeks ABI-007 in combination with carboplatin (AUC=6) in patients with ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

Study Status Information



Study Activation / Registration Date:	11/14/2006

IRB Review and Approval Date:	10/04/2006

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	up to 82

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 a histologic diagnosis of primary peritoneal carcinoma, fallopian tube or epithelial ovarian carcinoma, Stage III or IV, with either optimal (</= 1cm residual disease) or suboptimal residual disease following initial appropriate surgery.

2) Patients with the following histologically confirmed types of ovarian cancer are eligible: serous cystadenocarcinoma, mucinous cystadenocarcinoma, clear cell adenocarcinoma, adenocarcinoma (unspecified), Malignant Brenners tumor, endometrioid adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma and transitional cell carcinoma. Patients with extraovarian papillary serous cystadenocarcinoma are eligible.

3) Patients who do not have measurable disease may be included and will be assessed for toxicity and progression-free survival only. Measurable disease is NOT required but when present will be followed to assess response. For patients to be evaluable for response of measurable disease, tumors must be >/= 2.0 cm with conventional CT imaging or >/= 1.0 cm with spiral CT imaging.

4) No prior chemotherapy for ovarian cancer is permitted.

5) Patients must be entered no more than 12 weeks postoperatively.

6) ECOG performance status 0–2.

7) Age >/= 18 years.

8) Patient has the following blood counts at Baseline: ANC >/= 1.5 x 109 cells/L; platelets >/= 100 x 109 cells/L; Hgb >/= 9 g/dL.

9) Patient has the following blood chemistry levels at Baseline: AST (SGOT), ALT (SGPT) </= 2.5x upper limit of normal range (ULN); total bilirubin </= ULN; creatinine </=1.5 mg/dL.

10) Peripheral neuropathy Grade 0 or 1 by NCI CTCAE.

11) It is assumed that almost all patients will be status post bilateral oophorectomy. However, if female of childbearing potential, pregnancy test is negative (within 72 hours of the first dose of study drug) and the patient must agree to use an effective method to avoid pregnancy for the duration of the study.

12) Patients must have signed an approved informed consent and authorization permitting the release of personal health information.

Exclusion Criteria:

1) Patients who have received any prior treatment, other than initial debulking surgery, for the cancer being treated in this study. Patients may have received adjuvant chemotherapy for localized breast cancer, if the therapy was completed >/= 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.

2) Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation for localized cancer of the breast, head and neck or skin is permitted if it was completed >/= 3 years before registration in this study and if the patient remains free of recurrent metastatic disease.

3) Concurrent immunotherapy or hormonal therapy for ovarian cancer.

4) Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment for the disease.

5) Serious intercurrent medical or psychiatric illness, including serious active infection (i.e., requiring antibiotics).

6) Patients with borderline or low malignant potential tumors.

7) History of other malignancy within the last 5 years which could affect the diagnosis or assessment of ovarian cancer.

8) Patients who have received an invetigational drug within the previous 3 weeks.

9) Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered. Also, a patient may not enroll in such clinical trials while participating in this study.

10) Pregnant or nursing women.

11) Patients with unstable angina or those who have had myocardial infarction within the past 6 months. Patients with evidence of cardiac conduction abnormalities (e.g., bundle branch block, heart block) are eligible if their cardiac status has been stable for the 6 months prior to study entry.

12) Patients with prior hypersensitivity to both Taxol and Taxotere.

Links

Registration Number: NCT00407407
Study Information on Clinical Trials Registry (clinicaltrials.gov)