Ovarian Cancer

A Phase II Trial Of High Dose Chemotherapy With Autologous Stem Cell Support As Initial Treatment For Patients With Stage III Or IV Primary Debulked Epithelial Carcinoma Of The Ovary.

Objective:

To evaluate the pathologic complete response rate, progression-free and overall survival of patients with primary debulked and chemotherapy-responsive stage III or IV epithelial ovarian cancer treated with taxol/cisplatin chemotherapy followed by high-dose cyclophosphamide, mitoxantrone and carboplatin with autologous stem cell support.

Treatment:

Eligible patients will receive 3 cycles of taxol/cisplatin chemotherapy; patients without evidence of disease progression at that point will receive a fourth cycle of taxol/cisplatin followed by peripheral stem cell harvesting. Patients will then receive high-dose chemotherapy with cyclophosphamide, mitoxantrone and carboplatin and peripheral stem cell transplantation. Following hematopoietic recovery, patients will undergo second look surgery to evaluate the response to treatment.

Eligibility:

  1. All patients with pathologically confirmed stage III or IV epithelial carcinoma of the ovary who have undergone appropriate primary surgical staging and debulking are eligible.

     

  2. Maximal measurement of any single dimension of residual tumor following the completion of primary surgery must be 10 centimeters.

     

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

     

  4. Patients must be reevaluated and undergo second registration following the third cycle of taxol/cisplatin. Patients with measurable disease after initial surgery must have demonstrated a response to taxol/cisplatin in order to proceed to high-dose chemotherapy. Patients with nonmeasurable disease must demonstrate a lack of disease progression and a falling CA-125 level to proceed to high-dose chemotherapy.

     

  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, cardiac, pulmonary and hematology function.