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← Avopef: refractory Testicular Cancer

NCT00957905 · STUDY IN CONTEXT

Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

exploratory · NOT_POSTED

graded using the NCI CTCAE version 4.0.See adverse event section

Source null

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exploratory · NOT_POSTED

Progression-free Survival

Source null

→

exploratory · NOT_POSTED

Time to Tumor Response

Source null

→

primary · POSTED

Number of Participants with Partial Response (PR), Stable Disease (SD), Progression of Disease (POD) Per Response Evaluation Criteria In Solid Tumors Criteria" (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-testicular-cancer-avopef-9e524ceb
nct id
NCT00957905
trial label
Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors
applicability
unclear
applicability note
Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
4
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-avopef-9e524ceb
    nct id
    NCT00957905
    outcome key
    om-0001
    source section id
    NCT00957905-om-0001
    source outcome index
    1
    endpoint
    Toxicity
    endpoint definition
    graded using the NCI CTCAE version 4.0.See adverse event section
    time origin
    Up to 4 years
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-avopef-9e524ceb
    nct id
    NCT00957905
    outcome key
    om-0002
    source section id
    NCT00957905-om-0002
    source outcome index
    2
    endpoint
    Progression-free Survival
    endpoint definition
    Progression-free Survival
    time origin
    From treatment start until first documented progression or death, assessed up to 4 years
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-avopef-9e524ceb
    nct id
    NCT00957905
    outcome key
    om-0003
    source section id
    NCT00957905-om-0003
    source outcome index
    3
    endpoint
    Time to Tumor Response
    endpoint definition
    Time to Tumor Response
    time origin
    From treatment start until first documented CR or PR, assessed up to 4 years
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-avopef-9e524ceb
    nct id
    NCT00957905
    outcome key
    om-0000
    source section id
    NCT00957905-om-0000
    source outcome index
    0
    endpoint
    Objective Response Rate
    endpoint definition
    Number of Participants with Partial Response (PR), Stable Disease (SD), Progression of Disease (POD) Per Response Evaluation Criteria In Solid Tumors Criteria" (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
    time origin
    Within 3 courses of treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-avopef-9e524ceb
    nct id
    NCT00957905
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Part A (Alvocidib and Oxaliplatin)
    regimen
    Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00957905-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-avopef-9e524ceb
    nct id
    NCT00957905
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Part B (Alvocidib and FOLFOX)
    regimen
    Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    25
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00957905-om-0000#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-avopef-9e524ceb
    nct id
    NCT00957905
    harm key
    EG000
    source section id
    NCT00957905-ae
    event group key
    EG000
    event group label
    Part A (Alvocidib and Oxaliplatin)
    serious affected
    4
    serious at risk
    7
    other affected
    5
    other at risk
    7
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-testicular-cancer-avopef-9e524ceb
    nct id
    NCT00957905
    harm key
    EG001
    source section id
    NCT00957905-ae
    event group key
    EG001
    event group label
    Part B (Alvocidib and FOLFOX)
    serious affected
    7
    serious at risk
    29
    other affected
    23
    other at risk
    29
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice