NCT00004221

Brief Summary

Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have undergone surgery for stage III ovarian cancer. 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.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2002

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 25, 2003

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

January 28, 2000

Last Update Submit

August 8, 2017

Conditions

Malignant Ovarian Mixed Epithelial TumorOvarian Clear Cell CystadenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Mucinous CystadenocarcinomaOvarian Serous CystadenocarcinomaPrimary Peritoneal CarcinomaStage III Ovarian CancerUndifferentiated Ovarian Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Complete response defined as complete disappearance of all measurable and evaluable tumor documented at second-look surgery

    Up to 11 years

  • Indication of excessive toxicity defined as hospitalization > 14 days per course, delay of day 1 therapy > 14 days, or grade 3 (irreversible) or grade 4 vital organ toxicity (non-hematologic)

    Up to 11 years

Secondary Outcomes (2)

  • Overall survival

    Up to 11 years

  • PFS

    Up to 11 years

Study Arms (1)

Treatment (Combination chemotherapy, PBSC)

EXPERIMENTAL

See detailed description.

Drug: CarboplatinDrug: CyclophosphamideBiological: FilgrastimDrug: PaclitaxelProcedure: Peripheral Blood Stem Cell TransplantationDrug: Topotecan Hydrochloride

Interventions

CarboplatinDRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Treatment (Combination chemotherapy, PBSC)
CyclophosphamideDRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
Treatment (Combination chemotherapy, PBSC)
FilgrastimBIOLOGICAL

Given SQ

Also known as: Filgrastim XM02, G-CSF, Neupogen, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, rG-CSF, Tbo-filgrastim, Tevagrastim
Treatment (Combination chemotherapy, PBSC)
PaclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Treatment (Combination chemotherapy, PBSC)
Peripheral Blood Stem Cell TransplantationPROCEDURE

Undergo autologous peripheral blood stem cell transplantation

Also known as: PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplantation
Treatment (Combination chemotherapy, PBSC)
Topotecan HydrochlorideDRUG

Given IV

Also known as: Hycamptamine, Hycamtin, SKF S-104864-A, Topotecan HCl, topotecan hydrochloride (oral)
Treatment (Combination chemotherapy, PBSC)

Eligibility Criteria

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

You may qualify if:

  • Histologically proven optimally debulked stage III ovarian or primary peritoneal carcinoma
  • Any of the following subtypes:
  • Serous adenocarcinoma
  • Mucinous adenocarcinoma
  • Clear cell carcinoma
  • Transitional cell carcinoma
  • Endometrioid adenocarcinoma
  • Undifferentiated adenocarcinoma
  • Mixed epithelial adenocarcinoma
  • Adenocarcinoma, not otherwise specified
  • No ovarian carcinoma of low malignant potential (borderline)
  • Concurrent superficial endometrial or cervical carcinoma allowed if ovarian carcinoma more life threatening or limiting
  • Must have undergone appropriate primary surgical staging and debulking for ovarian carcinoma and have less than 1 cm of residual disease
  • No more than 8 weeks since prior surgical debulking
  • Must have Hickman catheter in place or be eligible for placement
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

CarboplatinCyclophosphamideFilgrastimGranulocyte Colony-Stimulating FactorPaclitaxelTaxesPeripheral Blood Stem Cell TransplantationTopotecan

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Russell Schilder

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2000

First Posted

August 25, 2003

Study Start

November 1, 1999

Primary Completion

February 6, 2002

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

US(1)