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Columbus, Ohio 43222

  • Ovarian Neoplasm

Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

PGT201


NCT ID:

NCT00069901


Secondary ID:


Study Acronym:


Brief Title:

Phase II CT-2103/Carboplatin in Ovarian Cancer


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cell Therapeutics


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

82


Enrollment Type:

Actual


Overall Contact Information

Official Name:Scott Stromatt, M.D.
Study Director
Cell Therapeutics

Study Dates

Start Date:February 2003
Completion Date:September 2006
Completion Type:Actual
Primary Completion Date:November 2005
Primary Completion Type:Actual
Verification Date:September 2008
Last Changed Date:September 18, 2008
First Received Date:October 2, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:CT-2103 (poly(L)glutamate-paclitaxel)
Intervention Type:Drug
Name:carboplatin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Cell Therapeutics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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