Phase II CT-2103/Carboplatin in Ovarian Cancer

Ovarian Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069901
• Other study ID #: PGT201
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2003
• Last updated: September 18, 2008
• Start date: February 2003
• Est. completion date: September 2006

Study information

• Verified date: September 2008
• Source: CTI BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 2006
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Neoplasm
• Ovarian Neoplasms

Intervention

Drug:
• CT-2103 (poly(L)glutamate-paclitaxel)

• carboplatin

Locations

Country	Name	City	State
United States	Arlington Fairfax Hematology Oncology	Arlington	Virginia
United States	Chattanooga GYN-Oncology	Chattanooga	Tennessee
United States	South Carolina Oncology Assoicates	Columbia	South Carolina
United States	Gynecology, Oncology, and Pelvic Surgery Associates, Inc.	Columbus	Ohio
United States	California Cancer Care	Greenbrae	California
United States	Gynecology Oncology Associates	Greenbrae	California
United States	Resource Center for Gynecology/ Oncology	Kansas City	Missouri
United States	Baptist Regional Cancer Center	Knoxville	Tennessee
United States	University of Louisville	Louisville	Kentucky
United States	Aurora Health Care, Inc.	Milwaukee	Wisconsin
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Upstate New York Cancer Research and Education Foundation	Rochester	New York
United States	Guthrie Foundation for Education and Research	Sayre	Pennsylvania
United States	Pacific Gynecology Specialists	Seattle	Washington
United States	Swedish Cancer Institute	Seattle	Washington
United States	Raben and Fldman Research Associates	South Miami	Florida
United States	Stockton Hematology Oncology Medical	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
CTI BioPharma

Country where clinical trial is conducted

United States,