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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasm

Thank you

Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Scott Stromatt, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Cell Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

PGT201

NCT ID:

NCT00069901

Start Date:

February 2003

Completion Date:

September 2006

Related Keywords:

  • Ovarian Neoplasm
  • ovarian cancer
  • paclitaxel
  • carboplatin
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Swedish Cancer InstituteSeattle, Washington  98104
Pacific Gynecology SpecialistsSeattle, Washington  98104
Baptist Regional Cancer CenterKnoxville, Tennessee  37920
University of LouisvilleLouisville, Kentucky  40202
California Cancer CareGreenbrae, California  94904
Arlington Fairfax Hematology OncologyArlington, Virginia  22205
Gynecology Oncology AssociatesGreenbrae, California  
Stockton Hematology Oncology MedicalStockton, California  95204
Raben and Fldman Research AssociatesSouth Miami, Florida  33143
Resource Center for Gynecology/ OncologyKansas City, Missouri  64132
Upstate New York Cancer Research and Education FoundationRochester, New York  98104
Gynecology, Oncology, and Pelvic Surgery Associates, Inc.Columbus, Ohio  43222
Guthrie Foundation for Education and ResearchSayre, Pennsylvania  18840
South Carolina Oncology AssoicatesColumbia, South Carolina  29203
Chattanooga GYN-OncologyChattanooga, Tennessee  37403
Aurora Health Care, Inc.Milwaukee, Wisconsin  53201