Phase II CT-2103/Carboplatin in Ovarian Cancer - Full Text View

Sponsor:	Cell Therapeutics
Information provided by:	Cell Therapeutics
ClinicalTrials.gov Identifier:	NCT00069901

Purpose

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	Intervention	Phase
Ovarian Neoplasm	Drug: CT-2103 (poly(L)glutamate-paclitaxel) Drug: carboplatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	CT-2103/Carboplatin for Patients With Newly Diagnosed Stage III or IV Ovarian or Primary Peritoneal Cancer: A Phase 2 Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin Paclitaxel Poliglumex

U.S. FDA Resources

Further study details as provided by Cell Therapeutics:

Enrollment:	82
Study Start Date:	February 2003
Study Completion Date:	September 2006
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069901

Locations

United States, California
Gynecology Oncology Associates
Greenbrae, California, United States
California Cancer Care
Greenbrae, California, United States, 94904
Stockton Hematology Oncology Medical
Stockton, California, United States, 95204
United States, Florida
Raben and Fldman Research Associates
South Miami, Florida, United States, 33143
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Missouri
Resource Center for Gynecology/ Oncology
Kansas City, Missouri, United States, 64132
United States, New York
Upstate New York Cancer Research and Education Foundation
Rochester, New York, United States, 98104
United States, Ohio
Gynecology, Oncology, and Pelvic Surgery Associates, Inc.
Columbus, Ohio, United States, 43222
United States, Pennsylvania
Guthrie Foundation for Education and Research
Sayre, Pennsylvania, United States, 18840
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
United States, South Carolina
South Carolina Oncology Assoicates
Columbia, South Carolina, United States, 29203
United States, Tennessee
Baptist Regional Cancer Center
Knoxville, Tennessee, United States, 37920
Chattanooga GYN-Oncology
Chattanooga, Tennessee, United States, 37403
United States, Virginia
Arlington Fairfax Hematology Oncology
Arlington, Virginia, United States, 22205
United States, Washington
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Swedish Cancer Institute
Seattle, Washington, United States, 98104
United States, Wisconsin
Aurora Health Care, Inc.
Milwaukee, Wisconsin, United States, 53201

Sponsors and Collaborators

Cell Therapeutics

Investigators

Study Director:

Scott Stromatt, M.D.

Cell Therapeutics

More Information

No publications provided

Study ID Numbers:	PGT201
Study First Received:	October 2, 2003
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00069901 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cell Therapeutics:

ovarian cancer
paclitaxel
carboplatin

Additional relevant MeSH terms:

Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Carboplatin

Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009