Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

filgrastim

+ amifostine trihydrate

+ carboplatin

BiologicalDrugProcedure
Who is being recruted

Urogenital Diseases+16

+ Genital Diseases

+ Adnexal Diseases

Until 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: December 1996
See protocol details

Summary

Principal SponsorUniversity of Chicago
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00003136
Principal SponsorUniversity of Chicago
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Until 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesCarcinoma, Ovarian EpithelialOvarian Neoplasms

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Cyclophosphamide (40mg/kg/day on days -6, -5 and -4), Carboplatin (1600, 1700 or 1800 mg/m2 on days -6, -5, -4 and -3), Amifostine (910 mg/m2 on days -6, -5, -4 and -3), Peripheral blood stem cell transplantation (day 0), G-CSF (beginning day 4)

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Chicago Cancer Research Center

Chicago, United StatesOpen University of Chicago Cancer Research Center in Google Maps
CompletedOne Study Center