You are viewing an expired study

This study is not currently recruiting Study Participants on If you would like to find active studies please browse nearby listings below.

Click here to view additional nearby studies or search for clinical trials.

Sayre, Pennsylvania 18840

  • Ovarian Neoplasm


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.


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:




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:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


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:


Study Design:

Allocation: Non-Randomized, Endpoint Classificati

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


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

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:

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

This study is not currently recruiting Study Participants. The form below is not enabled.