Ovarian Cancer Clinical Trial
Official title:
Phase I-II Study of Tandem Cycles of High Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Support in Women With Persistent, Refractory or Recurrent Advanced (Stage III or IV), Epithelial Ovarian Cancer
Verified date | December 2002 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with peripheral stem cell
transplantation may allow the doctor to give higher doses of chemotherapy and kill more
tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and autologous
peripheral stem cell transplantation in treating patients with recurrent or persistent
epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically proven persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer following at least 3 courses of initial standard platinum based chemotherapy OR have radiologic evidence of recurrence with a CA125 greater than 100 - Initial stage IV disease having a complete response following platinum based therapy allowed - No brain metastases - Not eligible for other high priority national or institutional study PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Greater than 2 months Hematopoietic: - WBC greater than 3000/mm3 - Absolute neutrophil count greater than 1500/mm3 - Platelet count greater than 100,000/mm3 Hepatic: - Bilirubin less than 1.5 times normal - SGOT or SGPT less than 1.5 times normal - PT/PTT within normal limits Renal: - BUN less than 1.5 times normal - Creatinine less than 1.5 times normal - Creatinine clearance greater than 55 mL/min Cardiovascular: - LVEF at least 45% Other: - Not pregnant or nursing - HIV negative - No prior malignancy other than curatively treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or breast cancer if the risk of recurrence is sufficiently low - No serious illness that would prevent treatment PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: - Not specified Radiotherapy: - At least 3 weeks since prior radiotherapy Surgery: - Not specified Other: - No concurrent acetaminophen |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Herbert Irving Comprehensive Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Herbert Irving Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
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