Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information
Chemotherapy in Treating Patients With Ovarian Germ Cell Tumors
| 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.Related Publications
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 Lead Organizations
Gynecologic Oncology Group
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| Stephen Williams, MD, Protocol chair | |
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Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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