Ovarian Cancer

Phase II Trial Of High-Dose Chemotherapy With Autologous Stem Cell Support As Treatment for Patients With Stage III or IV Platinum-Sensitive Epithelial Carcinoma Of The Ovary.

Objective:

To evaluate the progression-free and overall survival of patients with chemotherapy responsive stage III or IV epithelial ovarian cancer treated with high-dose cyclophosphamide, mitoxantrone and carboplatin and autologous stem cell support.

Treatment:

Patients with persistent or recurrent ovarian cancer who are eligible for study must have achieved a maximal tumor measurement of 2 centimeters prior to the time of high-dose chemotherapy. This may be achieved by conventional chemotherapy and/or surgery as the clinical situation warrants. These patients and those with non-bulky disease will be treated with high-dose cyclophosphamide, mitoxantrone and carboplatin and peripheral stem cell transplantation.

Eligibility:

  1. Patients must have pathologically confirmed stage III or IV epithelial carcinoma of the ovary and have demonstrated chemotherapy- sensitivity to at least 4 cycles of one cisplatin or carboplatin-based regimen. This will therefore include the following patient groups:

    a. Patients who have responded to initial chemotherapy and undergo second-look surgery which demonstrates either a complete pathologic response or evidence of residual ovarian cancer.

    b. Patients who have responded to initial chemotherapy and have evidence of persistent ovarian cancer by physical exam or radiologic studies.

    c. Patients who have relapsed greater than 6 months following a complete response to platinum-based chemotherapy.

     

  2. The maximal measurement of any single dimension of tumor at the time of high-dose chemotherapy must be 2cm.

     

  3. Patients with CNS or bone marrow involvement are not eligible.

     

  4. Patients must not have received prior radiation therapy for ovarian cancer nor pelvic radiation therapy at any prior time.

     

  5. Patients must be of physiologic age 65.

     

  6. Patients must have an ECOG performance status of 0 or 1.

     

  7. Patients must have adequate renal, hepatic, pulmonary, cardiac and hematologic function.