MDACC Study Summary 2005-0780

Study Summary
No. 2005-0780:.......Fallopian Tube; Ovary; Peritoneum......Karen H. Lu......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2005-0780

Study Title:	A Multi-Institutional Study of Proteomic Evaluation of Epithelial Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile of Relapse

Physician

New Patient Referral



Name:	Karen H. Lu	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:	713-745-8902 Contact us about clinical trials

General Information



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

Phase of Study:	N/A	Return Visit:	Patients will be seen in follow-up every three months. Clinical needs may dictate a more frequent evaluation.

Treatment Agents:	None	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 collect blood and urine to be used to develop better tests that may help detect ovarian cancer (the term ovarian cancer refers to ovarian cancer, fallopian tube cancer, and primary peritoneal cancer).

Study Objectives / Outcomes

Primary Objectives

To create a multi-institutional repository from which investigations of serum proteomic signature profile(s) of epithelial ovarian cancer remission and relapse will be developed and validated;
To determine the sensitivity and specificity of the proteomic signature profiles for relapse.
To determine if proteomic evaluation is able to classify patient disease progression to the same extent or better than that which can be done with CA125 alone.

Secondary Objectives

To compare the sensitivity and specificity of the proteomic signature profiles to those of CA-125.
To identify the temporal relationship between a rise in CA-125 value versus the development of proteomic signature profiles of relapse.
To identify the sensitivity and specificity of the proteomic signature profiles combined with CA-125.
To sequence key features of protein patterns in the model.
To develop a shared specimen resource from women with known ovarian cancer for testing future biomarker models.
To detect the impact of study participation on quality of life
To collect epidemiological data for patients in the target population

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	02/27/2006

Study Type:	Laboratory

Recruitment Status:	Closed

Projected Accrual:	400

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) All patients in first complete response from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma as defined by: normal CA-125, normal post-hysterectomy physical exam, no evidence of disease on abdominopelvic CT scan (or other noninvasive reassessment, e.g. MRI). PET scans are not acceptable for confirmation of complete response.

2) Pathology of the primary tumor must be confirmed by the registering center prior to protocol entry.

3) Entry within 9 weeks of completion of final cycle of chemotherapy (within 12 weeks of last administration of chemotherapy).

4) S/P surgical debulking and completion of primary therapy with platinum/taxane -containing chemotherapy of no more than 8 total cycles.

5) Patients who undergo second look laparotomy or laparoscopy and have microscopic residual disease but who elect not to have treatment will be eligible to enroll.

6) Histology slides adequate to confirm the pathology and staging must be submitted to the coordinating center within 3 months of enrollment. (If available, a sample of frozen primary tumor should also be forwarded)

7) Patients must be able and willing to provide informed consent to participate in the trial.

8) Patients must have laboratory evidence of good end organ function by the following criteria: (1) AST(SGOT) and ALT(SGPT) </= 2.5 X institutional upper limit of normal; (2) creatinine </= 2.0 OR creatinine clearance >/= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal. The upper limit of normal is based upon each registering center's laboratory normal ranges.

Exclusion Criteria:

1) Patients with nonepithelial ovarian cancer, mixed epithelial/nonepithelial ovarian cancer (i.e., Mixed Malignant Mullerian Tumors), or tumors of low malignant potential. Patients with stage I or II epithelial ovarian, fallopian tube, or primary peritoneal cancer.

2) Patients may not be receiving chemotherapy (therapeutic or consolidation), maintenance, alternative therapy, or radiation therapy. No anti-cancer therapy of any kind is allowed while the patient is on-study. Replacement hormonal therapy is allowed but must be clearly indicated on the case report forms submitted. Hormonal anti-cancer therapies such as tamoxifen and raloxifene will not be permitted while on study.

3) Patients with a life expectancy of less than 6 months for any reason.

4) Patients with a history of other invasive malignancies within the past five years prior to enrollment except for curatively treated carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, concomitant stage I endometrial cancer, or basal or squamous cell skin cancers.

5) Complementary and alternative agent use is discouraged on this study due to the possibility that the use of these agents may alter the serum protein pattern. The Institutional Principal Investigator will have discretion as to whether complementary or alternative agent usage will prevent eligibility on a case by case basis.

Links

Registration Number: NCT00119353
Study Information on Clinical Trials Registry (clinicaltrials.gov)