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

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ClinicalTrials.gov Identifier: NCT00551122
Recruitment Status : Unknown
Verified October 2007 by University of Southampton.
Recruitment status was:  Recruiting
First Posted : October 30, 2007
Last Update Posted : January 23, 2013
Sponsor:
Collaborator:
University Hospital Southampton NHS Foundation Trust
Information provided by (Responsible Party):
University of Southampton

Study Description
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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.


Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor Biological: filgrastim Biological: lenograstim Biological: pegfilgrastim Drug: cisplatin Drug: gemcitabine hydrochloride Drug: ifosfamide Drug: paclitaxel Phase 1 Phase 2

Detailed Description:

OBJECTIVES:

  • To determine the maximum tolerated dose (MTD) of gemcitabine hydrochloride when administered with TIP chemotherapy comprising paclitaxel, ifosfamide, and cisplatin with growth factor support (Gem-TIP) in patients with progressive or relapsed metastatic germ cell tumors.
  • To compare the MTD of the Gem-TIP regimen with the MTD determined in a previous Medical Research Council study of TIP alone.
  • To compare the degree of dose intensification achieved with Gem-TIP chemotherapy with that achieved in the prior study of TIP chemotherapy alone.
  • To assess the dose of gemcitabine hydrochloride that can be delivered with the TIP regimen in these patients.
  • To measure response rates and failure-free survival of patients treated with Gem-TIP alone.
  • To assess the utility of PET scanning after Gem-TIP chemotherapy in these patients.

OUTLINE: This is a multicenter, phase I dose-escalation study of gemcitabine hydrochloride followed by a phase II study.

  • Phase I: Patients receive gemcitabine hydrochloride IV over 30 minutes and paclitaxel IV over 3 hours on day 1, cisplatin IV over 4 hours on days 1-5, and ifosfamide IV over 1 hour on days 2-6. Patients also receive filgrastim or lenograstim (G-CSF) subcutaneously (SC) on days 7-18 or until blood counts recover OR pegfilgrastim SC once on day 6. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • Phase II: An additional cohort of 14 patients is treated as in phase I at the MTD determined in phase I.

After completion of study therapy, patients are followed periodically for up to 1 year and then at the investigator's discretion.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Multicentre Trial of Salvage Chemotherapy With Gem-TIP for Relapsed Germ Cell Cancer
Study Start Date : November 2006
Estimated Primary Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Paclitaxel, gemcitabine, cisplatin, ifosfamide

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: filgrastim
Biological: lenograstim
Biological: pegfilgrastim
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: ifosfamide
Drug: paclitaxel


Outcome Measures
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Primary Outcome Measures :
  1. Maximum tolerated dose of gemcitabine hydrochloride when administered with TIP chemotherapy comprising paclitaxel, ifosfamide, and cisplatin with growth factor support (phase I) [ Time Frame: end of study ]
  2. Response rates (phase I) [ Time Frame: end of study ]
  3. Failure-free survival (phase I) [ Time Frame: end of study ]
  4. Utility of positron emission tomography scanning after Gem-TIP chemotherapy (phase I) [ Time Frame: end of study ]
  5. Degree of dose intensification achieved with Gem-TIP chemotherapy relative to a previous Medical Research Council study with TIP alone (phase II) [ Time Frame: end of study ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551122


Locations
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United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust Recruiting
Birmingham, England, United Kingdom, B15 2TH
Contact: Michael H. Cullen, MD    0121-627-2444      
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: G. Mead, MD    44-23-8079-8639      
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Robert A. Huddart, MD    44-20-8661-3457    robert.huddart@icr.ac.uk   
Sponsors and Collaborators
University of Southampton
University Hospital Southampton NHS Foundation Trust
Investigators
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Study Chair: G. Mead, MD University Hospital Southampton NHS Foundation Trust
More Information
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Responsible Party: University of Southampton
ClinicalTrials.gov Identifier: NCT00551122    
Other Study ID Numbers: CDR0000572096
USCTU-UR1002-GEM-TIP
EU-20769
EUDRACT-2004-004804-19
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: October 2007
Keywords provided by University of Southampton:
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
Additional relevant MeSH terms:
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Neoplasms
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Nervous System Diseases
Genital Neoplasms, Male
Testicular Diseases
Gemcitabine
 Paclitaxel
Ifosfamide
Lenograstim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents