Clinical trial · Interventional
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
NCT00069901CI-TRIAL-00001690completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasm | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| CT-2103 (poly(L)glutamate-paclitaxel) | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.