The patient will receive paclitaxel and carboplatin in high dose before one stem cell infusion. When the patient has recovered sufficiently from this first cycle they will be given high dose topotecan and etopophos in combination and then given a second stem cell infusion. When the patient has recovered sufficiently from this second cycle, they will be given high dose thiotepa and then given a third stem cell infusion. Following these procedures, the doctor will assess several forms of data which are routinely analyzed after high dose chemotherapy, including recovery of marrow function, side effects of the treatment, possible relapse of the cancer, and survival.

Condition	Treatment or Intervention	Phase
Ovarian Neoplasms	Drug: induction chemo and G-CSF  Device: central venous catheter  Procedure: stem cell harvest  Drug: Paclitaxel/Carboplatin  Procedure: stem cell infusion  Drug: Topotecan/Etopophos  Procedure: stem cell infusion  Drug: Thiotepa therapy  Procedure: stem cell infusion	Phase I Phase II

To determine eligibility for this study, a laparoscopy or laparotomy may be required in order to prove the extent of disease and to study the response to therapy.

Induction Therapy: The study will begin with one or two cycles of chemotherapy, after which the patient will receive injections of G-CSF. In addition, a central venous catheter will be placed, to provide easy access to do blood tests, give drugs and blood transfusions, and allow blood stem cells to be taken from the patient and then re-infused.

Peripheral blood stem cell harvest: Peripheral blood stem cells will be taken from the patient by a process called pheresis. Blood will be withdrawn into a sterile container. The stem cells will be removed, and the rest of the blood will be returned to the patient, either through the same vein or into a vein in the opposite arm. This procedure will take about 4 hours each time. This procedure is done in the outpatient area and will be repeated daily from 2-4 times. If an adequate number of cells has not been collected after the first cycle of paclitaxel, the patient will receive a second cycle and the pheresis will be repeated.

Paclitaxel/Carboplatin therapy: After induction therapy and peripheral blood stem cell harvest are completed, the patient will receive high dose carboplatin and paclitaxel given over 2 days as an outpatient. These are medicines which are known to have significant activity in ovarian cancer. After the chemotherapy, the patient will receive a portion of the blood stem cells. Following the stem cell reinfusion, G-CSF will be given by injection under the skin once a day, until recovery of the patients white blood cells.

Topotecan/Etopophos therapy: After recovering from the first course of high dose chemotherapy, the patient will receive high dose topotecan and etopophos given separated by 2 days. After the chemotherapy, the patient will receive a second portion of the blood stem cells. Following the stem cell reinfusion, G-CSF will be given by injection under the skin once a day, until recovery of the patient's white blood cells.

Thiotepa therapy: After recovering from the second phase of treatment, the patient will receive high dose thiotepa as an outpatient. After the chemotherapy, the patient will receive a third portion of the blood stem cells. Following the stem cell reinfusion, G-CSF will be given by injection under the skin once a day, until recovery of the patient's white blood cells.

Patients will be asked to have periodic follow-up evaluations performed to determine response at various stages post-BMT. It is suggested that these follow-up visits be performed every 3 months for the first year after treatment on this protocol, every 6 months during the second post-treatment year, then once a year until death. Patients may have these follow-up evaluations done at the office of their primary/local oncologist. Exams should include CT of chest, abdomen and pelvis, CA125 evaluation, physical exam, and various blood tests including Chem 20, hepatic profile, and any other blood work deemed necessary by the patient's primary/local oncologist.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

1) Histologically-confirmed and reviewed at CPMC persistent or recurrent epithelial ovarian cancer or fallopian tube cancer following at least 3 cycles of initial standard platinum-based therapy OR have radiologic evidence of recurrence with a CA125 > 100. Patients with primary peritoneal cancer will also be eligible. Histologic tissue may be obtained through fine needle biopsy (including cytology), outpatient biopsy, or operative laparoscopy or laparotomy. Patients who have initial stage IV disease and achieve a clinical or pathologic complete response following standard platinum-based therapy will be eligible as well.

2) Ineligible for other high priority national or institutional study.

3) Prior therapy allowed: >3 weeks since RT or CT (6 weeks for nitrosureas).

4) Clinical Parameters: Life expectancy > 2 months. Brain CT or MRI no metastases. Left ventricular ejection fraction >45%. Performance status 0-1 (ECOG). HIV negative.

5) Required initial laboratory data: White cell count >3000/ul. ANC >1,500/ul. Platelet count >100,000/ul. BUN <1.5 x normal Creatinine <1.5 normal Creatinine clearance >55 mg/minute Bilirubin <1.5 normal SGOT or SGPT <1.5 x normal PT/PTT WNL CA125 baseline obtained

6) Informed Consent: Each patient must be completely aware of the nature of her disease process and must willingly give consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.

7) No prior malignancy other than curatively treated carcinoma in-situ of the cervix, non-melanoma skin cancer, or breast cancer if, in the opinion of the treating physician, the risk of recurrence from the breast cancer is sufficiently low.

8) No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).

9) Non pregnant, non lactating.

10) Patients may participate in other research protocols including studies relating to the use of other colony stimulating factors, gene therapy, stem cell mobilization.

New York
      Columbia-Presbyterian Medical Center, New York,  New York,  10032,  United States; Recruiting

Study ID Numbers:  CAMP 20; IRB # 7866
Record last reviewed:  April 2002
Record first received:  April 25, 2002
ClinicalTrials.gov Identifier:  NCT00034320
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10