Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, ifosfamide, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with paclitaxel, ifosfamide, and cisplatin, and to see how well they work in treating patients with progressive or relapsed metastatic germ cell tumors.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Geographic Reach

1 country

3 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed

12 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed

5 days until next milestone

First Posted

Study publicly available on registry

October 30, 2007

Completed

5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed

Last Updated

January 23, 2013

Status Verified

October 1, 2007

Enrollment Period

6.4 years

First QC Date

October 25, 2007

Last Update Submit

January 22, 2013

Conditions

Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor

Keywords

recurrent malignant testicular germ cell tumortesticular seminomarecurrent ovarian germ cell tumorstage IV ovarian germ cell tumorstage III malignant testicular germ cell tumortesticular choriocarcinoma and seminomatesticular embryonal carcinoma and seminomatesticular embryonal carcinoma and teratoma with seminomatesticular embryonal carcinoma and yolk sac tumor with seminomatesticular yolk sac tumor and teratoma with seminomarecurrent extragonadal non-seminomatous germ cell tumorrecurrent extragonadal seminomastage IV extragonadal non-seminomatous germ cell tumorstage IV extragonadal seminomarecurrent extragonadal germ cell tumorovarian mixed germ cell tumoradult central nervous system germ cell tumor

Outcome Measures

Primary Outcomes (5)

Maximum tolerated dose of gemcitabine hydrochloride when administered with TIP chemotherapy comprising paclitaxel, ifosfamide, and cisplatin with growth factor support (phase I)
end of study
Response rates (phase I)
end of study
Failure-free survival (phase I)
end of study
Utility of positron emission tomography scanning after Gem-TIP chemotherapy (phase I)
end of study
Degree of dose intensification achieved with Gem-TIP chemotherapy relative to a previous Medical Research Council study with TIP alone (phase II)
end of study

Study Arms (1)

Paclitaxel, gemcitabine, cisplatin, ifosfamide

EXPERIMENTAL

Day 1 Dexamethasone sodium phosphate 25mg I/V ) before Chlorphenamine 10mg I/V 30 - 60 mins ) paclitaxel Ranitidine 50mg I/V ) Paclitaxel - 175 mg m2 I/V in 500ml normal saline over 3 hours Gemcitabine - 1200mg per m2 I/V in 500ml normal saline over 30 mins Days 1-5 Cisplatin 20mg per m2 in 1 litre normal saline over 4 hours 2 litres normal saline over 16 hours, each litre containing 10 mmol MgSO4 and 20mmol KCL. If urine output is insufficient (less than 600ml per 6 hours) or if excessive weight gain (greater than 2kg) 100 - 200ml 10% mannitol should be used. Alternatively, low dose frusemide (20mg I/V) can be used. Days 2 - 6 Ifosfamide 1G per m2 + MESNA 0.5G m2 in 500 ml normal saline over 1 hour after the cisplatin infusion. MESNA 0.5G m2 to be included in first 1 litre post cisplatin hydration bag Pegylated G-CSF will be given on day 7 as an alternative to daily G-CSF.

Biological: filgrastimBiological: lenograstimBiological: pegfilgrastimDrug: cisplatinDrug: gemcitabine hydrochlorideDrug: ifosfamideDrug: paclitaxel