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NCT00423852 · OUTCOME

Response

Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin · Source last updated 2016-05-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
2 year

What was measured

Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary) Complete Response (CR): A complete response is defined as one of the following: * Complete disappearance of all clinical and radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). * Complete disappearance of all biochemical evidence of disease with resection of residual radiographic masses that prove to be negative for residual GCT; this includes both mature teratoma and necrotic debris (CR to chemotherapy) for a minimum of 4 weeks. * Complete disappearance of all biochemical evidence of disease with complete surgical excision of all residual radiographic masses that, if pathologically positive for residual malignant GCT, show margins to microscopically free of disease (CR to chemotherapy + surgery). Patients must be free of disease for a minimum of 4 weeks.

Groups in this outcome

Chemotherapy With Stem Cell Support

This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38. filgrastim carboplatin ifosfamide paclitaxel autologous hematopoietic stem cell transplantation peripheral blood stem cell transplantation

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Chemotherapy With Stem Cell Support23

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy With Stem Cell Support12Not reportedNot reportedNot reportedNot reported
Incomplete Response (IR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy With Stem Cell Support6Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy With Stem Cell Support5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Incomplete Response (IR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Partial Response (PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary) Complete Response (CR): A complete response is defined as one of the following: * Complete disappearance of all clinical and radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). * Complete disappearance of all biochemical evidence of disease with resection of residual radiographic masses that prove to be negative for residual GCT; this includes both mature teratoma and necrotic debris (CR to chemotherapy) for a minimum of 4 weeks. * Complete disappearance of all biochemical evidence of disease with complete surgical excision of all residual radiographic masses that, if pathologically positive for residual malignant GCT, show margins to microscopically free of disease (CR to chemotherapy + surgery). Patients must be free of disease for a minimum of 4 weeks.
groups
  1. description
    This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38. filgrastim carboplatin ifosfamide paclitaxel autologous hematopoietic stem cell transplantation peripheral blood stem cell transplantation
    id
    OG000
    title
    Chemotherapy With Stem Cell Support
param Type
NUMBER
reporting Status
POSTED
time Frame
2 year
title
Response
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice