Ovarian Cancer

ECOG G0164

A Randomized, Controlled Intergroup Trial of Salvage Therapy With Paclitaxel And Carboplatin vs. Salvage Therapy With Stem Cell Supported High Dose Of Carboplatin, Mitoxantrone And Cyclophosphamide In Patients With Persistent Low Volume Ovarian Cancer And Response To Primary Therapy

Objectives:

1. To compare outcomes (progression-free survival and survival) of salvage therapy with either standard dose paclitaxel and carboplatin or bone marrow reconstitution following high dose carboplatin, mitroxantrone and cyclophosphamide in patients with drug-sensitive, low-volume persistant ovarian cancer after standard therapy.

2. To compare toxicities and QOL of these groups.

Eligibility:

INITIAL INCLUSION / EXCLUSION:
1. Must have established stage III epithelial ovarian cancer and have undergone adequate primary surgical staging for ovarian cancer. Patients with suboptimal stage III or optimal stage III with greater than microscopic disease after primary surgery will be eligible.

2. The following types of histology are eligible:

Clear-cell adenoca
Serous adenoca
Endometrial adenoca
Undifferentiated cancer
Mixed epithelial cancer
Transitional cell cancer
Mucinous adenoca
Malignant Brenner’s Tumor

3. Must have completed ò 4, but ó 6 cycles of platinum complex containing chemo with a second drug consisting of either cytoxan or taxol. No more than 12 weeks since last chemo and second surgery, and no more than 6 weeks from surgery until randomization.

4. Must have reassessment surgery at completion of primary chemo guidelines, including:

a.) An incision adequate to explore entire abdominal cavity.
b.) Direct inspection of all peritoneal surfaces, and lymph node sampling.
c.) Bx proof of persistent disease.
d.) Laparascopy is acceptable as reassessment

5. Eligible patients must demonstrate at least a partial response (PR) to primary chemo including:

a.) Optimally debulked after primary surgery - eligible only if microscopic
disease is documented at reassessment surgery. b.) Suboptimally debulked after primary surgery is <=1 cm in greatest dimension prior to secondary debulking.
c.) Registration may not occur until a method of payment for possible transplant is secured.

6. No history of any anthracycline exposure. No history of any prior malignancy except for adequately treated basal / squamous cell skin cancer or CIS of cervix.

7. Creatinine clearance >= 60 cc / min; bilirubin <=1.5 mg / dl; and AST <=3 x ULN; ACG >=1000 / mm³; platelet >=100,000 / mm³.

8. GOG P.S. 0-1. Must be <=65 years old at time of registration.