Clinical trial NCT00069901: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasm
Keywords: ovarian cancer
paclitaxel
carboplatin
Lead sponsor: CTI BioPharma
Sponsor class: INDUSTRY
First posted: 2003-10-06
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: California Cancer Care
state: California
city: Greenbrae
country: United States
facility: Gynecology Oncology Associates
state: California
city: Stockton
country: United States
facility: Stockton Hematology Oncology Medical
state: California
city: South Miami
country: United States
facility: Raben and Fldman Research Associates
state: Florida
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Kansas City
country: United States
facility: Resource Center for Gynecology/ Oncology
state: Missouri
city: Rochester
country: United States
facility: Upstate New York Cancer Research and Education Foundation
state: New York
city: Columbus
country: United States
facility: Gynecology, Oncology, and Pelvic Surgery Associates, Inc.
state: Ohio
city: Philadelphia
country: United States
facility: Albert Einstein Cancer Center
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Foundation for Education and Research
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Assoicates
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga GYN-Oncology
state: Tennessee
city: Knoxville
country: United States
facility: Baptist Regional Cancer Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Fairfax Hematology Oncology
state: Virginia
city: Seattle
country: United States
facility: Pacific Gynecology Specialists
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Milwaukee
country: United States
facility: Aurora Health Care, Inc.
state: Wisconsin
Study officials:
affiliation: CTI BioPharma
name: Scott Stromatt, M.D.
role: STUDY_DIRECTOR
References: