Overview
Phase II CT-2103/Carboplatin in Ovarian Cancer
Status:
Completed
Completed
Trial end date:
2006-09-01
2006-09-01
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
CTI BioPharmaTreatments:
Albumin-Bound Paclitaxel
Carboplatin
Paclitaxel
Paclitaxel poliglumex
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.