ChemoFx® PRO - A Post-Market Data Collection Study

Sponsor

Precision Therapeutics (Industry)

Overall Status

Terminated

CT.gov ID

NCT00669422

Collaborator

(none)

2,756

Enrollment

Locations

Duration (Months)

41.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will collect patient demographic, oncology history, and physician reported outcome information following the initial round of chemotherapy received after a commercial ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for further sub-studies.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Uterine Neoplasms Endometrial Cancer Vaginal Cancer Vulvar Cancer Cervical Cancer

Detailed Description

The traditional treatment course for new cases of many cancers is cytoreductive surgery followed by chemotherapy. Unfortunately, despite high initial response rates to treatment, the majority of patients recur. The use of ineffective chemotherapy can result in unnecessary toxicity and costs, delay of more effective treatment, and the potential for the development of cross-resistance to additional drugs. The ability to individualize therapy by providing the treating physician with ex vivo response information on a panel of drugs should aid in the selection of effective therapy for individual patients, thus resulting in improved outcomes.

ChemoFx® is a drug response marker that quantifies an individual cancer patient's probable tumor response to various chemotherapeutic and biologic agents-providing both sensitivity and resistance information. In a retrospective study, it was demonstrated that patients treated with a regimen that the ChemoFx® test said the patients' cells would be sensitive to, corresponded to a 3 times longer progression free interval.

In the PT-206 ChemoFx PRO® study, patients will be followed through treatment, until the patient progresses or a significant change in chemotherapy occurs. This data will be collected and analyzed to identify potential patient cohorts for the development of hypotheses for future sub-study analysis. Also, tumor pathology slides and excess tumor cells (if available) will be used to characterize common polymorphisms in drug metabolizing enzymes as well as other molecular markers potentially associated with tumor response.

The PT-206 ChemoFx PRO® Study seeks to enroll an estimated 3,000 patients from 150 academic and community-based physicians in the U.S. The patients will be treated with drugs and/or drug combinations based on the medical judgment of the treating physician. This study is not randomized.

Study Design

Study Type:

Observational

Actual Enrollment :

2756 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes

Study Start Date :

Oct 1, 2006

Actual Study Completion Date :

Oct 1, 2012

Outcome Measures

Primary Outcome Measures

To collect physician reported outcomes after the first chemotherapy utilized following the receipt of a final report from ChemoFx® in solid tumor malignancies for the generation of hypotheses for further sub-study. [24-36 Months depending on Disease Status]

Secondary Outcome Measures

Identify possible enhancements of the predictive and prognostic capabilities of the assay through the inclusion of molecular markers. [24-36 Months depending on Disease Status]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient has been diagnosed with a solid tumor malignancy and their physician has received a final report for ChemoFx® after August 1, 2006
Chemotherapy must be clinically indicated for treatment of the patient's qualifying disease
Patient must be at least 18 years of age
Patient must have signed an IRB approved informed consent form for the data collection study prior to entry of data into the enrollment form in the database.

Exclusion Criteria:

Patient pathology shows benign pathology for sample submitted
Patient is not indicated to receive chemotherapy for their disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of South Alabama	Mobile	Alabama	United States	36688
3	University of California San Francisco	San Francisco	California	United States	94115
4	Women's Cancer Center of Southern California	Sherman Oaks	California	United States	91403
5	GOA Torrance Memorial	Torrance	California	United States	91403
6	Hartford Hospital	Hartford	Connecticut	United States	06106
7	Yale University	New Haven	Connecticut	United States	06111
8	South Florida Center for Gynecologic Oncology	Boca Raton	Florida	United States	33487
9	West Coast Gynecologic Oncology	Clearwater	Florida	United States	33756
10	Florida Center for Gynecologic Oncology	Coconut Creek	Florida	United States	33073
11	Comprehensive Gynecologic Oncology	Delray Beach	Florida	United States	33444
12	Caruso and Gates MDs PA	Fort Lauderdale	Florida	United States	33308
13	Florida Gynecologic Oncology	Fort Myers	Florida	United States	33901
14	Gynecologic Oncology Associates	Hollywood	Florida	United States	33021
15	Sarasota Memorial Hospital	Sarasota	Florida	United States	34239
16	South Miami Gynecologic Oncology Group	South Miami	Florida	United States	33143
17	Palm Beach Cancer Institute	West Palm Beach	Florida	United States	33401
18	Southeastern Gynecologic Oncology, LLC	Riverdale	Georgia	United States	30274
19	Memorial Health University Medical Center	Savannah	Georgia	United States	31404
20	The Queens' Medical Center	Honolulu	Hawaii	United States	96813
21	Rush University	Chicago	Illinois	United States	60612
22	NorthShore Medical Group	Evanston	Illinois	United States	60201
23	Indiana University	Indianapolis	Indiana	United States	46202
24	Women's Cancer Center	Covington	Louisiana	United States	70433
25	CHRISTUS Schumpert Health System	Shreveport	Louisiana	United States	71101
26	Sinai Hospital	Baltimore	Maryland	United States	21215
27	Women's Health Specialists	Silver Springs	Maryland	United States	20852
28	UMass Memorial Hospital	Worcester	Massachusetts	United States	01605
29	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
30	Henry Ford Health System	Detroit	Michigan	United States	48202
31	Gynecologic Oncology of West Michigan	Grand Rapids	Michigan	United States	49546
32	Mississippi Oncology Associates	Jackson	Mississippi	United States	39216
33	Atlantic Health Systems	Morristown	New Jersey	United States	07962
34	Jersey Shore University Medical Center	Neptune	New Jersey	United States	07765
35	Gara M Sommers MD	Teaneck	New Jersey	United States	07066
36	Cooper Health System	Voorhees	New Jersey	United States	08043
37	Women's Cancer Care Associates	Albany	New York	United States	12208
38	St. John's Episcopal Hospital	Atlantic Beach	New York	United States	11509
39	Montefiore Medical Center	Bronx	New York	United States	10461
40	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
41	North Shore LIJ Health System	Manhassett	New York	United States	11030
42	Columbia University Medical Center	New York	New York	United States	10032
43	New York Downtown Hospital	New York	New York	United States	10038
44	Hope: A Women's Cancer Center	Asheville	North Carolina	United States	28806
45	Blumenthal Cancer Center	Charlotte	North Carolina	United States	28204
46	Presbyterian Gynecologic Oncology	Charlotte	North Carolina	United States	28233
47	Duke University Medical Center	Durham	North Carolina	United States	27710
48	North Hanover Regional Medical Center	Wilmington	North Carolina	United States	28402
49	University of Cincinnati	Cincinnati	Ohio	United States	45267
50	OSU Gynecologic Oncology	Columbus	Ohio	United States	43026
51	Oklahoma Gynecologic Oncology Group	Oklahoma City	Oklahoma	United States	73112
52	Oregon Health & Science University	Portland	Oregon	United States	97239
53	Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania	United States	15224
54	The Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224
55	Women & Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905
56	Medical University of South Carolina Hospital	Charleston	South Carolina	United States	29403
57	Sandford USD Health System	Sioux Falls	South Dakota	United States	57105
58	Chattanooga Gynecologic Oncology	Chattanooga	Tennessee	United States	37403
59	Chattanooga's Program in Women's Oncology	Chattanooga	Tennessee	United States	37403
60	Thomas W. McDonald MD	Knoxville	Tennessee	United States	37922
61	North Texas Gynecologic Oncology	Dallas	Texas	United States	75251
62	Brooke Army Medical Center	Ft. Sam Houston	Texas	United States	78234
63	South Texas Gynecologic Oncology	San Antonio	Texas	United States	78258
64	North Virigina Pelvic Surgery Associates	Annandale	Virginia	United States	22003
65	Carilion Clinic Gynecologic Oncology	Roanoke	Virginia	United States	24016
66	Mohammed Ashraf MD	Morgantown	West Virginia	United States	26505
67	Aurora West Allis Medical Center	West Allis	Wisconsin	United States	53227