Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care, Treatment Closed no age specified Other NBSG-9204 NCI-V92-0153

Objectives

I.  Determine whether double platinum therapy with cisplatin and carboplatin 
offers any significant improvement in frequency of objective response 
(clinical and pathological), progression-free interval, and duration of 
survival over prior regimens for patients with Stage III/IV epithelial ovarian 
cancer.

II.  Evaluate the toxicity of double platinum therapy, and determine whether 
newer antiemetic therapy with ondansetron or granisetron and growth factor 
therapy with granulocyte colony stimulating factor can decrease the known 
toxicities of this regimen.

Entry Criteria

Disease Characteristics:

Histologically confirmed, Stage III/IV epithelial adenocarcinoma of the ovary

Appropriate surgery required, with appropriate tissue submitted for histologic
exam

Measurable or evaluable disease required, including CA-125 levels

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy

Surgery:
  No more than 4 weeks since surgery

Patient Characteristics:

Age:
  Not specified

Performance status:
  ECOG 0-2

Hematopoietic:
  AGC at least 1,000
  Platelets at least 100,000

Hepatic:
  (in the absence of tumor involvement)
  Bilirubin less than 2 x normal
  SGOT less than 2 x normal
  Alkaline phosphatase less than 2 x normal

Renal:
  Creatinine less than 2.0 mg/dl

Other:
  No serious active infection requiring antibiotics
  No major organ allografts
  No second malignancy within the last 5 years except nonmelanomatous skin
     cancer

Expected Enrollment

Up to 30 patients will be entered over 24 months.  If no responses are seen in 
the first 14 evaluable patients, the study will be terminated.

Outline

2-Drug Combination Chemotherapy with Antiemetic Prophylaxis and Hematologic 
Toxicity Attenuation.  Cisplatin, CDDP, NSC-119875; Carboplatin, CBDCA, 
NSC-241240; with Ondansetron or Granisetron (Kytril); and Granulocyte Colony 
Stimulating Factor (Amgen), G-CSF, NSC-614629.

Hall DJ, Kincaid K: Phase II trial of Cisplatin and Paraplatin in stages III and IV epithelial ovarian cancer: National Biotherapy Study Group protocol. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-795, 281, 1995.

Trial Contact Information

Trial Lead Organizations

Cancer Biotherapy Research Group

Don Hall, MD, Protocol chair(Contact information may not be current)		Ph: 949-760-5543