MedDataX Logo

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

NCT ID: NCT00531687

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

not relevant

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Testicular Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GCT

cisplatin Paclitaxel gemcitabine

Group Type OTHER

Paclitaxel

Intervention Type DRUG

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.

Cisplatin

Intervention Type DRUG

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.

Gemcitabine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

taxol Gemzar

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gedske Daugaard

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gedske Daugaard, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Oncology 5073, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Relapse testis cancer 2007

Identifier Type: -

Identifier Source: org_study_id