Phase II CT-2103/Carboplatin in Ovarian Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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CT-2103 is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer. The objective of this trial is to evaluate the toxicity, estimate the response rate, progression-free survival and overall survival in patients with newly diagnosed stage III or IV ovarian or primary peritoneal carcinoma treated with CT-2103 in combination with carboplatin.

Official Title
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CT-2103/Carboplatin for Patients With Newly Diagnosed Stage III or IV Ovarian or Primary Peritoneal Cancer: A Phase 2 Study

Conditions
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Ovarian Neoplasm

Intervention / Treatment
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* Drug: CT-2103 (poly(L)glutamate-paclitaxel)
* Drug: carboplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CT-2103 (poly(L)glutamate-paclitaxel)|nan|
|Drug: carboplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer, paclitaxel, carboplatin