Phase II CT-2103/Carboplatin in Ovarian Cancer

Sponsor

CTI BioPharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00069901

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of CT-2103 (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients with Stage III or IV ovarian or primary peritoneal cancer.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Neoplasm	Drug: CT-2103 (poly(L)glutamate-paclitaxel) Drug: carboplatin	Phase 2

Detailed Description

CT-2103 is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer. The objective of this trial is to evaluate the toxicity, estimate the response rate, progression-free survival and overall survival in patients with newly diagnosed stage III or IV ovarian or primary peritoneal carcinoma treated with CT-2103 in combination with carboplatin.

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

CT-2103/Carboplatin for Patients With Newly Diagnosed Stage III or IV Ovarian or Primary Peritoneal Cancer: A Phase 2 Study

Study Start Date :

Feb 1, 2003

Actual Primary Completion Date :

Nov 1, 2005

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion criteria:

Histologically-confirmed stage III or IV ovarian carcinoma or primary peritoneal cancer patients who have had appropriate debulking surgery for ovarian or peritoneal carcinoma.
Patients must be recovered from initial surgery and must enter this study no later than 12 weeks after such surgery.
ECOG performance score of 0, 1, or 2.
absolute neutrophil count (ANC) at least 1,500/µL.
platelet at least 100,000/µL.
hemoglobin at least 10 g/dL.
creatinine no greater than 1.5 times the upper limit of normal (ULN).
bilirubin no greater than 1.5 x ULN (if liver metastases are not present, SGOT and SGPT no greater than 2.5 x ULN, if liver metastases are present, SGOT and SGPT may be no greater than 5 x ULN.
Alkaline phosphatase no greater than 2.5 x ULN.

Exclusion:

Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas)
Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from sites other than the ovary, and low malignant potential tumors including so called micropapillary serous carcinomas.
Synchronous primary endometrial cancer or history of primary endometrial cancer.
Evidence of any other invasive malignancies present within the 3 years before this study, with the exception of non-melanoma skin cancer and other specific malignancies as noted above.
Any prior treatment, other than initial debulking surgery, for the cancer being treated in this study.
Patients may have received prior adjuvant chemotherapy for localized breast cancer, if the therapy was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
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 at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
Administration of other investigational drugs within 26 weeks before the first treatment in this study. Toxic manifestations of previous treatments (except alopecia) must have been stable for 4 weeks.
Presence of active hepatitis, either acute or chronic.
Presence of active infection requiring antibiotic or antiviral therapy.
Pregnant women or nursing mothers.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Cancer Care	Greenbrae	California	United States	94904
2	Gynecology Oncology Associates	Greenbrae	California	United States
3	Stockton Hematology Oncology Medical	Stockton	California	United States	95204
4	Raben and Fldman Research Associates	South Miami	Florida	United States	33143
5	University of Louisville	Louisville	Kentucky	United States	40202
6	Resource Center for Gynecology/ Oncology	Kansas City	Missouri	United States	64132
7	Upstate New York Cancer Research and Education Foundation	Rochester	New York	United States	98104
8	Gynecology, Oncology, and Pelvic Surgery Associates, Inc.	Columbus	Ohio	United States	43222
9	Albert Einstein Cancer Center	Philadelphia	Pennsylvania	United States	19141
10	Guthrie Foundation for Education and Research	Sayre	Pennsylvania	United States	18840
11	South Carolina Oncology Assoicates	Columbia	South Carolina	United States	29203
12	Chattanooga GYN-Oncology	Chattanooga	Tennessee	United States	37403
13	Baptist Regional Cancer Center	Knoxville	Tennessee	United States	37920
14	Arlington Fairfax Hematology Oncology	Arlington	Virginia	United States	22205
15	Pacific Gynecology Specialists	Seattle	Washington	United States	98104
16	Swedish Cancer Institute	Seattle	Washington	United States	98104
17	Aurora Health Care, Inc.	Milwaukee	Wisconsin	United States	53201