NCT00004077

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 II trial to study the effectiveness of combining paclitaxel, ifosfamide, and cisplatin in treating patients who have metastatic testicular cancer that has recurred following treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 1996

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1996

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

December 19, 2013

Status Verified

January 1, 2001

First QC Date

December 10, 1999

Last Update Submit

December 18, 2013

Conditions

Testicular Germ Cell Tumor

Keywords

stage III malignant testicular germ cell tumorrecurrent malignant testicular germ cell tumortesticular embryonal carcinomatesticular choriocarcinomatesticular teratomatesticular yolk sac tumortesticular embryonal carcinoma and teratomatesticular embryonal carcinoma and yolk sac tumortesticular yolk sac tumor and teratomatesticular choriocarcinoma and yolk sac tumortesticular choriocarcinoma and embryonal carcinomatesticular choriocarcinoma and teratoma

Interventions

cisplatinDRUG
ifosfamideDRUG
paclitaxelDRUG

Eligibility Criteria

Age16 Years - 64 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Metastatic nonseminomatous germ cell tumor of the testis * In first relapse following first line treatment with bleomycin, etoposide, and cisplatin * Biopsy proven germ cell tumor OR * Rising tumor markers (alpha fetoprotein and/or human chorionic gonadotropin) * No brain metastases PATIENT CHARACTERISTICS: Age: * 16 to 64 Performance status: * 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Glomerular filtration rate greater than 50 mL/min Other: * No other prior malignancy except curatively treated nonmelanomatous skin cancer or superficial bladder cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior experimental drugs

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

Sponsors & Collaborators

Study Sites (1)

Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Related Publications (1)

  • Mead GM, Cullen MH, Huddart R, Harper P, Rustin GJ, Cook PA, Stenning SP, Mason M; MRC Testicular Tumour Working Party. A phase II trial of TIP (paclitaxel, ifosfamide and cisplatin) given as second-line (post-BEP) salvage chemotherapy for patients with metastatic germ cell cancer: a medical research council trial. Br J Cancer. 2005 Jul 25;93(2):178-84. doi: 10.1038/sj.bjc.6602682.

    PMID: 15999102RESULT

MeSH Terms

Conditions

Testicular Germ Cell TumorTesticular NeoplasmsTeratoma, TesticularEndodermal Sinus TumorTeratomaCarcinoma, Embryonal

Interventions

CisplatinIfosfamidePaclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersMesonephromaNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenes

Study Officials

  • Malcolm D. Mason, MD

    Velindre NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 10, 1999

First Posted

January 27, 2003

Study Start

May 1, 1996

Study Completion

July 1, 2005

Last Updated

December 19, 2013

Record last verified: 2001-01

Locations

GB(1)