Phase II CT-2103/Carboplatin in Ovarian Cancer

Completed · Phase 2

Conditions studied: Ovarian Neoplasm

In brief

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.

Key facts

Study ID

NCT00069901

Run by

CTI BioPharma

People needed

82

Starts

2003-02-01

Expected to finish

2006-09-01

Last updated by the study team

2008-09-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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