Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information

Alternate Title

Chemotherapy in Treating Patients With Ovarian Germ Cell Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	any age	NCI	GOG-90

Objectives

I.  Evaluate the effect of induction chemotherapy with BEP 
(cisplatin/etoposide/bleomycin) followed by consolidation with VAC 
(vincristine/dactinomycin/cyclophosphamide) in previously untreated patients 
with advanced ovarian germ cell tumors.

II.  Evaluate the effect of BEP chemotherapy in patients with recurrent or 
progressive disease during or after previous non-cisplatin-containing 
chemotherapy.

III.  Investigate further the relevant prognostic factors.

IV.  Evaluate the acute and chronic toxicity of such chemotherapy, 
particularly on gonadal and reproductive function.

V.  Evaluate the effect of chemotherapy on menstrual status and reproductive 
function in patients in whom the uterus and one tube and ovary are preserved.

Entry Criteria

Disease Characteristics:

Histologically confirmed malignant germ cell tumors of the ovary with
incompletely resected Stage II or advanced (Stage III/IV) disease

  Confirmation of recurrent or persistent disease by biopsy, surgery, x-ray,
  CT, or a steady rise in AFP and beta-HCG titers required

Completely resected Stage I/II/III disease excluded (eligible for protocol
GOG-78)

Dysgerminoma patients not suitable for radiotherapy eligible (closed to
dysgerminoma patients as of 8/7/95)

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior etoposide, bleomycin, or cisplatin
  Prior VAC (vincristine/dactinomycin/cyclophosphamide) allowed

Endocrine therapy:
  Not specified

Radiotherapy:
  Prior pelvic irradiation allowed (initial etoposide dose reduced 20% in
  these patients)

Surgery:
  No more than 6 weeks since any surgery
  Recovery from prior surgery required

Patient Characteristics:

Age:
  Any age

Performance status:
  Any status

Hematopoietic:
  AGC at least 1,500
  WBC at least 3,000
  Platelets at least 100,000

Hepatic:
  (in the absence of metastatic tumor)
  Bilirubin no more than 1.5 x normal
  SGOT no more than 3 x normal
  Alkaline phosphatase no more than 3 x normal

Renal:
  Impaired renal function allowed provided close attention is paid to
     instructions for administration of cisplatin, for modification of drug
     dosages, and for monitoring renal toxicity (patients with obstructive
     uropathy or renal dysfunction secondary to tumor should receive the full
     dose of cisplatin)
  Intrinsic renal disease considered unrelated to tumor with creatinine
     greater than 2.0 mg/dl excludes

Pulmonary:
  No severe pulmonary impairment (unless due to metastatic disease)

Other:
  No poor wound healing
  No severe malnutrition (unless patient is currently receiving
     hyperalimentation)
  No uncontrolled infection
  No uncontrolled bleeding
  No second malignancy other than nonmelanomatous skin cancer

Expected Enrollment

30 evaluable patients with no prior treatment and 17 to 30 evaluable 
previously treated patients will be required; the active phase of this study 
will be 2.5 to 3 years for untreated patients and 4 to 5 years for previously 
treated patients.

Outline

Patients with tumors other than pure dysgerminoma who have had no prior 
chemotherapy receive Induction and Consolidation, while patients who have had 
prior chemotherapy and those with pure dysgerminoma receive Induction only.  
(Closed to dysgerminoma patients as of 8/7/95.)

Induction:  3-Drug Combination Chemotherapy.  BEP:  Bleomycin, BLEO, 
NSC-125066; Etoposide, VP-16213, VP-16, NSC-141540; Cisplatin, cis-Platinum, 
CDDP, NSC-119875.

Consolidation:  3-Drug Combination Chemotherapy.  VAC:  Vincristine, VCR, 
NSC-67574; Dactinomycin, Actinomycin-D, DACT, NSC-3053; Cyclophosphamide, CTX, 
NSC-26271.

Champion V, Williams SD, Miller A, et al.: Quality of life in long-term survivors of ovarian germ cell tumors: a Gynecologic Oncology Group study. Gynecol Oncol 105 (3): 687-94, 2007.[PUBMED Abstract]

Gershenson DM, Miller AM, Champion VL, et al.: Reproductive and sexual function after platinum-based chemotherapy in long-term ovarian germ cell tumor survivors: a Gynecologic Oncology Group Study. J Clin Oncol 25 (19): 2792-7, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Stephen Williams, MD, Protocol chair		Ph: 317-278-0070; 888-600-4822 Email: stdwilli@IUPUI.edu