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Phase II Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer After First Line Chemotherapy
This study is currently recruiting participants.
Verified by Rigshospitalet, Denmark, September 2007
Sponsored by: Rigshospitalet, Denmark
Information provided by: Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00531687
  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 Relapse
Drug: cisplatin, gemcitabine, paclitaxel
Phase II

MedlinePlus related topics: Cancer Testicular Cancer
Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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. · ·

Secondary Outcome Measures:
  • 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

Study Start Date: September 2007
  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 > 3x109/l, ANC > 1,5x109/l, platelet count > 100x109/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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531687

Contacts
Contact: Gedske Daugaard, MD, DMSc 0045 35454677 gedske.daugaard@rh.regionh.dk

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

Study ID Numbers: Relapse testis cancer 2007
Study First Received: September 18, 2007
Last Updated: September 18, 2007
ClinicalTrials.gov Identifier: NCT00531687  
Health Authority: Denmark: Danish Dataprotection Agency;   Denmark: Danish Medicines Agency;   Denmark: Ethics Committee

Study placed in the following topic categories:
Genital Neoplasms, Male
Gonadal Disorders
Testicular Diseases
Endocrine System Diseases
Urogenital Neoplasms
Testicular Neoplasms
Genital Diseases, Male
Malignant germ cell tumor
Cisplatin
Paclitaxel
Testicular cancer
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009