Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer

This study has suspended participant recruitment.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Gedske Daugaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00531687
First received: September 18, 2007
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

Study Objectives:

Primary objective

  • The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP.

Secondary Objectives

  • Overall survival
  • Progression free survival
  • Response rates (RECIST)
  • Duration of response
  • To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP

Condition Intervention Phase
Testicular Cancer
Drug: Paclitaxel
Drug: Cisplatin
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Primary objective · The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP. · · [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary Objectives · Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Secondary Objectives · Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Secondary Objectives · Response rates (RECIST) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Secondary Objectives · Duration of response [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Secondary Objectives · To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: September 2007
Estimated Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paclitaxel

    Paclitaxel 175 mg/m2 day 1 (3 hour infusion)

    Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered.

    Other Name: taxol
    Drug: Cisplatin

    cisplatin 50 mg/m2 day 1 and 2

    Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered.

    Drug: Gemcitabine

    gemcitabine 1000mg/m2 days 1 and 8 (in a 30 minute infusion)

    Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered

    Other Name: Gemzar
Detailed Description:

not relevant

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed germ cell tumor (seminoma or non-seminoma) with measurable metastatic disease either by radiography (at a site which has previously not been irradiated) or elevation of alpha fetoprotein (AFP) and/or elevation of beta-human chorionic gonadotropin (beta-HCG);
  • Patient previously treated with standard BEP (3 or 4 cycles) with relapse 1 months or more after favorable response on previous chemotherapy (CR or PR)
  • Male
  • Age greater than or equal to 18 years;
  • Performance status 0,1,2 or 3
  • WBC > 3000 mill/l, ANC > 1500 mill/l, platelet count > 100.000 mill/l; serum bilirubin < 1.5 x the upper limit of normal;
  • Adequate renal function (Glomerular Filtration Rate (GFR) >60 ml/min). GFR will be assessed by direct measurement (EDTA clearance or creatinine clearance)
  • signed informed consent;

Exclusion Criteria:

  • Uncontrolled active severe clinical infection (CTC grade 3 or 4).
  • Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), including expected difficulty of follow-up related to mental disorders.
  • Grade 2 or greater peripheral neuropathy according to the CTC, version 3.0.
  • Second malignancy other than basal or squamous cell skin cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531687

Locations
Denmark
Department of Oncology 5073, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Gedske Daugaard, MD, DMSc Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Gedske Daugaard, Associate professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00531687     History of Changes
Other Study ID Numbers: Relapse testis cancer 2007
Study First Received: September 18, 2007
Last Updated: February 20, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
relapse

Additional relevant MeSH terms:
Testicular Neoplasms
Neoplasms, Germ Cell and Embryonal
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Gemcitabine
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on July 22, 2014