Clinical trial · Interventional

Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors

Phase I/II Multicentre Trial of Salvage Chemotherapy With Gem-TIP for Relapsed Germ Cell Cancer

NCT00551122CI-TRIAL-00009059GemTIPunknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain and Central Nervous System Tumors	—	UNRESOLVED	—
Extragonadal Germ Cell Tumor	Extragonadal Germ Cell Tumor	ONTOLOGY_EXACT	0.98
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Testicular Germ Cell Tumor	Testicular Germ Cell Tumor	ONTOLOGY_EXACT	0.90

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
cisplatin	Drug	Cisplatin	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
gemcitabine hydrochloride	Drug	Gemcitabine	ALIAS
ifosfamide	Drug	Ifosfamide	ALIAS
lenograstim	Biological	—	UNRESOLVED
paclitaxel	Drug	Paclitaxel	ALIAS
pegfilgrastim	Biological	Pegfilgrastim	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Paclitaxel, gemcitabine, cisplatin, ifosfamide
description
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.
interventionNames
1. Biological: filgrastim
2. Biological: lenograstim
3. Biological: pegfilgrastim
4. Drug: cisplatin
5. Drug: gemcitabine hydrochloride
6. Drug: ifosfamide
7. Drug: paclitaxel

Primary outcomes (5)

measure
Maximum tolerated dose of gemcitabine hydrochloride when administered with TIP chemotherapy comprising paclitaxel, ifosfamide, and cisplatin with growth factor support (phase I)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 16 Years
Maximum age: 60 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Meets the following criteria:

  * Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma

    * Unresectable metastatic disease
    * No completely resected cancer
  * Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer
* In first relapse after a single prior cisplatin-containing combination chemotherapy

  * Patients with late relapse (i.e., \> 2 years post initial chemotherapy) should be considered for surgery rather than chemotherapy, if technically feasible
* No patients with cerebral metastases alone

  * Progressive cerebral and systemic disease may be considered for this study, provided cranial irradiation is also considered as a component of care

PATIENT CHARACTERISTICS:

* Medically and psychologically fit to receive this intensive chemotherapy schedule
* WBC \> 3.5 times 10\^9/L
* Platelet count \> 130 times 10\^9/L
* Glomerular filtration rate ≥ 50 mL/min (as determined by 24 hour creatinine clearance or nuclear medicine technique)
* Fertile patients must use effective contraception
* No other prior malignancy except successfully treated nonmelanoma skin cancer or superficial bladder cancer
* No prior allergic reactions to cisplatin or other platinum compounds

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Nov 1, 2006
Primary completion: Apr 1, 2013
Completion: —
First posted: Oct 30, 2007
Last update posted: Jan 23, 2013
Enrollment: 23 (estimated)
Lead sponsor: University of Southampton OTHER
Collaborators: University Hospital Southampton NHS Foundation Trust
Keywords: recurrent malignant testicular germ cell tumor, testicular seminoma, recurrent ovarian germ cell tumor, stage IV ovarian germ cell tumor, stage III malignant testicular germ cell tumor, testicular choriocarcinoma and seminoma, testicular embryonal carcinoma and seminoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular yolk sac tumor and teratoma with seminoma, recurrent extragonadal non-seminomatous germ cell tumor, recurrent extragonadal seminoma, stage IV extragonadal non-seminomatous germ cell tumor, stage IV extragonadal seminoma, recurrent extragonadal germ cell tumor, ovarian mixed germ cell tumor, adult central nervous system germ cell tumor

Data updated 22 days agoSource updated Jan 23, 2013source: clinicaltrials

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