search
Back to results

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

Primary Purpose

Testicular Cancer

Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Paclitaxel
Cisplatin
Gemcitabine
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Testicular Cancer focused on measuring relapse

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Oncology 5073, Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

GCT

Arm Description

cisplatin Paclitaxel gemcitabine

Outcomes

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

Full Information

First Posted
September 18, 2007
Last Updated
September 29, 2017
Sponsor
Rigshospitalet, Denmark
search

1. Study Identification

Unique Protocol Identification Number
NCT00531687
Brief Title
Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer
Official Title
Phase II Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
not relevant

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Cancer
Keywords
relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GCT
Arm Type
Other
Arm Description
cisplatin Paclitaxel gemcitabine
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
taxol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Secondary Objectives · Overall survival
Time Frame
5 years
Title
Secondary Objectives · Progression free survival
Time Frame
5 years
Title
Secondary Objectives · Response rates (RECIST)
Time Frame
5 years
Title
Secondary Objectives · Duration of response
Time Frame
5 years
Title
Secondary Objectives · To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gedske Daugaard, MD, DMSc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology 5073, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs