Phase II CT-2103/Carboplatin in Ovarian Cancer
CT-2103/Carboplatin for Patients With Newly Diagnosed Stage III or IV Ovarian or Primary Peritoneal Cancer: A Phase 2 Study
1 other identifier
interventional
82
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2003
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 2, 2003
CompletedFirst Posted
Study publicly available on registry
October 6, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedSeptember 22, 2008
September 1, 2008
2.8 years
October 2, 2003
September 18, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CTI BioPharmalead
Study Sites (17)
California Cancer Care
Greenbrae, California, 94904, United States
Gynecology Oncology Associates
Greenbrae, California, United States
Stockton Hematology Oncology Medical
Stockton, California, 95204, United States
Raben and Fldman Research Associates
South Miami, Florida, 33143, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Resource Center for Gynecology/ Oncology
Kansas City, Missouri, 64132, United States
Upstate New York Cancer Research and Education Foundation
Rochester, New York, 98104, United States
Gynecology, Oncology, and Pelvic Surgery Associates, Inc.
Columbus, Ohio, 43222, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 18840, United States
South Carolina Oncology Assoicates
Columbia, South Carolina, 29203, United States
Chattanooga GYN-Oncology
Chattanooga, Tennessee, 37403, United States
Baptist Regional Cancer Center
Knoxville, Tennessee, 37920, United States
Arlington Fairfax Hematology Oncology
Arlington, Virginia, 22205, United States
Pacific Gynecology Specialists
Seattle, Washington, 98104, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Aurora Health Care, Inc.
Milwaukee, Wisconsin, 53201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scott Stromatt, M.D.
CTI BioPharma
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 2, 2003
First Posted
October 6, 2003
Study Start
February 1, 2003
Primary Completion
November 1, 2005
Study Completion
September 1, 2006
Last Updated
September 22, 2008
Record last verified: 2008-09