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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Terminated

CT.gov ID

NCT00531687

Collaborator

(none)

Enrollment

Location

Arm

109

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Testicular Cancer	Drug: Paclitaxel Drug: Cisplatin Drug: Gemcitabine	Phase 2

Detailed Description

not relevant

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: GCT cisplatin Paclitaxel gemcitabine	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 Names: 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 Names: Gemzar

Arm

Intervention/Treatment

Other: GCT

cisplatin Paclitaxel gemcitabine

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 Names:

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 Names:

Gemzar

Outcome Measures

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. · · [December 2010]

Secondary Outcome Measures

Secondary Objectives · Overall survival [5 years]
Secondary Objectives · Progression free survival [5 years]
Secondary Objectives · Response rates (RECIST) [5 years]
Secondary Objectives · Duration of response [5 years]
Secondary Objectives · To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oncology 5073, Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator: Gedske Daugaard, MD, DMSc, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gedske Daugaard, Associate professor, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT00531687

Other Study ID Numbers:

Relapse testis cancer 2007

First Posted:

Sep 19, 2007

Last Update Posted:

Oct 3, 2017

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Gedske Daugaard, Associate professor, Rigshospitalet, Denmark

relapse

Additional relevant MeSH terms:

Testicular Neoplasms

Neoplasms, Germ Cell and Embryonal

Gemcitabine

Paclitaxel

Study Results

No Results Posted as of Oct 3, 2017