Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2003-02-28
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CT-2103 (poly(L)glutamate-paclitaxel)
carboplatin
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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CTI BioPharma
INDUSTRY
Principal Investigators
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Scott Stromatt, M.D.
Role: STUDY_DIRECTOR
CTI BioPharma
Locations
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California Cancer Care
Greenbrae, California, United States
Gynecology Oncology Associates
Greenbrae, California, United States
Stockton Hematology Oncology Medical
Stockton, California, United States
Raben and Fldman Research Associates
South Miami, Florida, United States
University of Louisville
Louisville, Kentucky, United States
Resource Center for Gynecology/ Oncology
Kansas City, Missouri, United States
Upstate New York Cancer Research and Education Foundation
Rochester, New York, United States
Gynecology, Oncology, and Pelvic Surgery Associates, Inc.
Columbus, Ohio, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Guthrie Foundation for Education and Research
Sayre, Pennsylvania, United States
South Carolina Oncology Assoicates
Columbia, South Carolina, United States
Chattanooga GYN-Oncology
Chattanooga, Tennessee, United States
Baptist Regional Cancer Center
Knoxville, Tennessee, United States
Arlington Fairfax Hematology Oncology
Arlington, Virginia, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Aurora Health Care, Inc.
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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PGT201
Identifier Type: -
Identifier Source: org_study_id