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Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

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ClinicalTrials.gov Identifier: NCT01270724
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE January 4, 2011
First Posted Date  ICMJE January 5, 2011
Last Update Posted Date January 6, 2021
Study Start Date  ICMJE August 2010
Actual Primary Completion Date October 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
Response rate [ Time Frame: 4 months ]
To estimate response rate after at least two and up to four courses of induction chemotherapy with GemPOx regimen in patients with recurrent intracranial MMGCT
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
Response [ Time Frame: 4 months ]
To estimate response rate after at least two and up to four courses of induction chemotherapy with GemPOx regimen in patients with recurrent intracranial MMGCT
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
Toxicity levels [ Time Frame: 4 months ]
To assess the toxicity of GemPOx regimen in all patients with ICGCT (pure germinoma and MMGCT)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
Toxicity [ Time Frame: 4 months ]
To assess the toxicity of GemPOx regimen in all patients with ICGCT (pure germinoma and MMGCT)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)
Official Title  ICMJE A Phase II Clinical Trial of Induction Chemotherapy Regimen Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) Followed by a Single Cycle of High Dose Chemotherapy (HDC) and Autologous Hematopoietic Stem Cell Rescue (AuHSCR) for Patients With Recurrent or Progressive Intracranial Germ Cell Tumors
Brief Summary This study will look to see how well patients with relapsed or recurrent intracranial germ cell tumors respond to the new combination of chemotherapy (in induction)of Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) followed by consolidation chemotherapy and autologous stem cell rescue.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE CNS Germ Cell Tumor
Intervention  ICMJE Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.
Other Name: GemPOx
Study Arms  ICMJE Experimental: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)
Two to four cycles of induction therapy with open label GemPOx followed by consolidation and autologous stem cell transplant (ASCT).
Intervention: Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2019)
10
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2011)
28
Actual Study Completion Date  ICMJE December 9, 2019
Actual Primary Completion Date October 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ICGCT including pure germinoma and MMGCT.
  • Patients with histologically proven germinoma and MMGCT, including endodermal sinus tumor (yolk sac tumor), embryonal carcinoma, choriocarcinoma and mixed germ cell tumor will be eligible for the study.
  • Patients with mature/immature teratoma who have tumor marker elevations are eligible on this study.
  • Patient with ONLY mature and/or immature teratoma are ineligible in the absence of the tumor marker elevations.

Exclusion Criteria:

  • Patients with ICGCTs who are newly diagnosed are excluded from the study.
  • Patients with the diagnosis of mature or immature teratoma in the absence of tumor marker elevations are excluded from the study.
  • Patients who are pregnant or breastfeeding are excluded from the study.
  • Patients who have received previously a high dose chemotherapy regimen and autologous transplant are excluded from this study.
  • Patients who have received gemcitabine, oxaliplatin and/or paclitaxel are excluded from this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01270724
Other Study ID Numbers  ICMJE GemPOx
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Randal Olshefski, MD Nationwide Children's Hospital
PRS Account Nationwide Children's Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP