NCT00003064

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

April 18, 2003

Completed
Last Updated

January 6, 2014

Status Verified

December 1, 2002

First QC Date

November 1, 1999

Last Update Submit

January 3, 2014

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancerfallopian tube cancerprimary peritoneal cavity cancer

Interventions

filgrastimBIOLOGICAL
carboplatinDRUG
etoposide phosphateDRUG
paclitaxelDRUG
thiotepaDRUG
topotecan hydrochlorideDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

FilgrastimCarboplatinetoposide phosphatePaclitaxelThiotepaTopotecanPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesPhosphoramidesOrganophosphorus CompoundsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCamptothecinAlkaloidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Amy D. Tiersten, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 18, 2003

Study Start

January 1, 1997

Last Updated

January 6, 2014

Record last verified: 2002-12

Locations

US(1)