Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors
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|ClinicalTrials.gov Identifier: NCT01873326|
Recruitment Status : Active, not recruiting
First Posted : June 10, 2013
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Germ Cell Tumors||Drug: Paclitaxel Drug: Ifosfamide Drug: Cisplatin Drug: Mesna Drug: Bleomycin Drug: Etoposide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Trial of Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-Risk Germ Cell Tumors|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Paclitaxel, Ifosfamide and Cisplatin (TIP)
Paclitaxel 120 mg/m2 IV over 120-180 min Days 1 and 2 (+/- 4 days)* Mesna 120 mg/m2 IV (duration of infusion per institutional guidelines) approximately 30 minutes prior to initiation of ifosfamide Days 1-5 (+/- 4 days)* Ifosfamide 1200 mg/m2 IV over approximately 60 to 120 min Days 1-5 or per institutional guidelines (mixed 1:1 with mesna) (+/- 4 days)* Mesna** 1200 mg/m2 IV over approximately 60-120 min or per institutional guidelines (mixed 1:1 with ifosfamide)(+/- 4 days)* Cisplatin 20 mg/m2 IV over approximately 30 min Days 1-5 (+/- 4 days)*
**Additional mesna may be given at the discretion of the investigator
*Paclitaxel or Ifosfamide or Mesna or Cisplatin or any combination of these agents can be held as needed for patient safety on a given day between days 1-5 but must be made up within 4 days to avoid a protocol violation.
Active Comparator: Bleomycin, Etoposide and Cisplatin (BEP)
Cisplatin 20 mg/m2 IV over approximately 30 min Days 1-5 (+/- 4 days)* Etoposide 100 mg/m2 IV over approximately 1 hour Days 1-5 (+/- 4 days)* Bleomycin 30 U flat dose IV push Days 2, 8 and 15 (all +/- 4 days)
*Etoposide or Cisplatin or both can be held as needed for patient safety on a given day between days 1-5 but must be made up within 4 days to avoid a protocol violation.
- favorable best response rate [ Time Frame: 6 months ]Favorable best response is defined as complete response or partial response with negative tumor markers. Patients will be considered evaluable for the primary endpoint of favorable response within the first 6 months if they complete at least 3 cycles of study treatment (without switch to an alternative chemotherapy regimen) and achieve a confirmed partial response with negative markers or confirmed complete response (considered as favorable responses). Patients will also be considered evaluable for the primary endpoint if they develop disease progression during the treatment portion of the study regardless of how many cycles of chemotherapy they received or if they achieve an incomplete response after completion of study treatment (considered as not having a favorable response)."
- overall best response [ Time Frame: 3 years ]Overall best response refers to the best response achieved by a patient to either TIP or BEP over the course of the entire study.
- progression-free survival (PFS) [ Time Frame: 3 years ]Progression-free survival (PFS) will be calculated from the date of treatment start until disease progression, death, or last followup, whichever comes first. The following are included as PFS events: incomplete response (IR), relapse or disease progression, and death.
- overall survival (OS) [ Time Frame: 3 years ]Overall survival will be calculated from the date of treatment start until death, regardless of the cause.
- toxicity [ Time Frame: 30 days after completion of the last cycle of chemotherapy. ]Toxicity will be assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade of each toxicity will be recorded for each patient over the course of treatment (all cycles). Special emphasis will be placed on comparisons of the frequency of Grade 3/4 toxicities between the TIP and BEP arms.
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): NCT01873326
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|Stanford University Medical Center|
|Stanford, California, United States, 94305-5408|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|Memorial Sloan Kettering Monmouth|
|Middletown, New Jersey, United States, 07748|
|Memorial Sloan Kettering Bergen (Follow-up Only)|
|Montvale, New Jersey, United States, 07645|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering Nassau|
|Uniondale, New York, United States, 11553|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27514|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Darren Feldman, MD||Memorial Sloan Kettering Cancer Center|