NCT00002559

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, cisplatin, and ifosfamide in treating patients who have ovarian or testicular germ cell tumors that are refractory to platinum-containing chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P50-P75 for phase_1 ovarian-cancer

Timeline
Completed

Started Jan 1994

Longer than P75 for phase_1 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 1994

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 18, 2003

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

9 years

First QC Date

November 1, 1999

Last Update Submit

July 1, 2013

Conditions

Ovarian CancerTesticular Germ Cell Tumor

Keywords

recurrent malignant testicular germ cell tumorrecurrent ovarian germ cell tumor

Interventions

filgrastimBIOLOGICAL
cisplatinDRUG
ifosfamideDRUG
paclitaxelDRUG

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven germ cell tumor that is resistant to a platinum-based chemotherapy regimen * Active disease meeting 1 of the following conditions: * Measurable or evaluable disease * Elevated serum tumor markers (alpha-fetoprotein or human chorionic gonadotropin) * Unresectable residual disease after postchemotherapy surgery * Favorable prognostic factors for achieving a complete response (CR) to cisplatin-based salvage therapy required, including all of the following: * No more than 1 prior regimen or 6 prior courses of cisplatin * Testis or ovarian germ cell primary site * Prior CR to cisplatin therapy * Incomplete response to first-line therapy that was based on either carboplatin or a suboptimal regimen of cisplatin PATIENT CHARACTERISTICS: Age: * 15 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8.0 g/dL Hepatic: * Not specified Renal: * Creatinine clearance greater than 50 mL/min * Renal dysfunction due to ureteral obstruction by tumor allowed at the discretion of the principal investigator Cardiovascular: * If history of significant cardiac disease, evaluation and clearance by a cardiologist required prior to entry Other: * No active infection not well controlled on antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No prior paclitaxel or ifosfamide * At least 3 weeks since prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics * Recovered from recent surgery

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsTesticular Germ Cell TumorTesticular Neoplasms

Interventions

FilgrastimCisplatinIfosfamidePaclitaxel

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 DisordersGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenes

Study Officials

  • Robert J. Motzer, MD

    Memorial Sloan Kettering 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

September 18, 2003

Study Start

January 1, 1994

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

US(1)