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

NCT00531687 | Terminated Phase 2

• 1 other identifier: Relapse testis cancer 2007
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Testicular Cancer

Keywords

relapse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

GCT

OTHER

cisplatin Paclitaxel gemcitabine

Drug: Paclitaxel; Drug: Cisplatin; Drug: Gemcitabine

Interventions

Paclitaxel 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.

Also known as: taxol

GCT

Cisplatin 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.

GCT

Gemcitabine 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

Also known as: Gemzar

GCT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Oncology 5073, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Testicular Neoplasms; Recurrence

Interventions

Paclitaxel; Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Gedske Daugaard, MD, DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: September 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: October 1, 2016
• Last Updated: October 3, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)