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| Sponsored by: |
University of Chicago |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003136 |
Purpose
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 drugs and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of amifostine, carboplatin and cyclophosphamide, followed by peripheral stem cell transplantation, in treating patients with epithelial ovarian cancer or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Peritoneal Cavity Cancer |
Biological: filgrastim Drug: amifostine trihydrate Drug: carboplatin Drug: cyclophosphamide Procedure: peripheral blood stem cell transplantation |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I/II Dose Escalation Trial of Carboplatin With Amifostine Pretreatment to Augment High Dose Cyclophosphamide With Autologous Peripheral Blood Stem Cell Support for the Treatment of Patients With Epithelial Ovarian Cancer |
| Estimated Enrollment: | 28 |
| Study Start Date: | December 1996 |
OBJECTIVES: I. Determine the maximum tolerated dose of high dose carboplatin with a fixed dose of high dose cyclophosphamide with amifostine pretreatment, and peripheral blood stem cell rescue in patients with ovarian epithelial cancer. II. Monitor engraftment kinetics such as granulocyte and platelet recovery. III. Determine the toxic effects of this regimen in this patient population. IV. Document the response of this patient population to this regimen in terms of time to progression, event free survival, and overall survival.
OUTLINE: This is a dose escalation study. Patients undergo apheresis over 2-4 days to mobilize peripheral blood stem cells (PBSC). They then receive amifostine IV over 15 minutes. Fifteen minutes later, carboplatin is administered over 30 minutes on days -6 through -3. Cyclophosphamide IV is administered 1 hour after the carboplatin infusion is completed on days -6 through -4. PBSC are infused on day 0. Filgrastim (G-CSF) is administered beginning on day 4. Cohorts of 3-6 patients are treated at each dose level. At least 15 days must pass between the day of PBSC infusion and the next dose escalation. The dose limiting toxicity (DLT) is defined as the dose producing grade 3 or 4 nonhematologic toxicity in 2 of 6 patients. The maximum tolerated dose (MTD) is defined as one dose level below the DLT dose. At least 6 patients are treated at the MTD. Patients are followed monthly for 6 months, every 2-3 months for 1 year, and annually until death.
PROJECTED ACCRUAL: This study will accrue 28 patients over 2 years.
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven ovarian epithelial cancer or primary peritoneal carcinoma No tumors of low malignant potential Chemotherapy sensitive disease Relapse greater than 6 months after complete response to chemotherapy Partial response to most recent chemotherapy No more than 3 prior chemotherapy regimens Evidence of refractory or recurrent disease other than elevated CA-125 after primary surgery or chemotherapy; persistent disease need not be still present No brain metastases
PATIENT CHARACTERISTICS: Age: 65 and under Performance status: GOG 0 or 1 Life expectancy: Not specified Hematopoietic: WBC greater than 2500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal Renal: Creatinine clearance at least 50 mL/min Cardiovascular: Normal radionuclide cardiac scan with ejection fraction greater than 45% OR Normal left ventricular function by echocardiogram OR Cardiac clearance by Cardiology service Pulmonary: DLCO greater than 50% predicted Other: Not pregnant Hepatitis B and C negative HIV-1 negative
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637 | |
| Study Chair: | David L. Grinblatt, MD | University of Chicago |
More Information
| Study ID Numbers: | CDR0000065904, UCCRC-8433, ALZA-97-005-ii, NCI-V97-1357 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003136 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer peritoneal cavity cancer |
|
Radiation-Protective Agents Immunologic Factors Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Cyclophosphamide Genital Diseases, Female Peritoneal Diseases Ovarian Cancer Alkylating Agents Endocrine Gland Neoplasms Digestive System Neoplasms Ovarian Neoplasms Amifostine |
Genital Neoplasms, Female Endocrine System Diseases Carboplatin Abdominal Neoplasms Ovarian Epithelial Cancer Immunosuppressive Agents Recurrence Digestive System Diseases Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy Antineoplastic Agents, Alkylating Antirheumatic Agents |
|
Radiation-Protective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Cyclophosphamide Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Alkylating Agents Endocrine Gland Neoplasms |
Ovarian Neoplasms Digestive System Neoplasms Amifostine Genital Neoplasms, Female Endocrine System Diseases Carboplatin Abdominal Neoplasms Protective Agents Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Neoplasms Digestive System Diseases Myeloablative Agonists Antineoplastic Agents, Alkylating |
