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NCT00957905 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-03-10

This phase II trial is studying alvocidib and oxaliplatin to see how well they work when given with or without fluorouracil and leucovorin calcium in treating patients with relapsed or refractory germ cell tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin, fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving alvocidib together with oxaliplatin with or without fluorouracil and leucovorin calcium may kill more tumor cells.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate

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outcome · NOT POSTED

Toxicity

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outcome · NOT POSTED

Progression-free Survival

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outcome · NOT POSTED

Time to Tumor Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically confirmed germ cell tumor (GCT) * Seminoma or non-seminoma * Progressive disease after prior cisplatin-based therapy AND meets 1 of the following criteria: * Not considered to be a candidate for potentially curative therapy * Previously treated with high-dose chemotherapy regimens * Does not wish to undergo potentially curative high-dose therapy * Measurable or evaluable disease, as defined by 1 of the following criteria: * Unidimensionally measurable metastatic disease, defined as ≥ 1 malignant tumor mass that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional CT scan or MRI or as ≥ 10 mm by spiral CT scan * Bone lesions, ascites, peritoneal carcinomatosis, miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable disease * Patients with measurable disease only (i.e., normal tumor markers) must have ≥ 1 site of disease that has not been previously irradiated * Elevation of alpha-fetoprotein \> 15 ng/mL and/or elevation of beta-human chorionic gonadotropin \> 2.2 mIU/L * If tumor markers are not elevated, ≥ 1 site of measurable disease must be present * No known untreated CNS metastasis or primary CNS tumor * Patients who have undergone local treatment for brain metastases and whose brain metastases are demonstrated to be stable by repeat imaging studies performed ≥ 4 weeks after treatment are eligible * Karnofsky performance status 70-100% * ANC ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Serum creatinine ≤ 2.0 times upper limit of normal (ULN) * Total serum bilirubin ≤ 1.5 times ULN * AST and ALT ≤ 2.5 times ULN (unless elevation is due to underlying malignancy) * Not pregnant or nursing * Negative pregnancy test by ultrasound * Fertile patients must use effective contraception * Willing and able to comply with scheduled study visits, treatment plans, laboratory tests, follow-up tests for safety or effectiveness, and other study procedures * Mediport or Broviac access required for patients enrolled in part B of the study * No serious active infections * No significant (≥ grade 2) or persistent ongoing toxicity, including peripheral neuropathy, from prior therapy * None of the following within the past 6 months: * Myocardial infarction * Severe/unstable angina * Coronary/peripheral artery bypass graft * Symptomatic congestive heart failure * Cerebrovascular accident or transient ischemic attack * Pulmonary embolism * No contraindication to any of the study drugs * No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, interfere with the interpretation of study results, and, in the judgement of the investigator, may make the patient inappropriate for study entry * No concurrent anti-retroviral therapy for HIV-positive patients * Recovered from prior radiotherapy or surgery * Residual grade 1 toxicities allowed * No prior alvocidib * At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), immunotherapy, or radiotherapy * More than 4 weeks since prior major surgery * No other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy * No concurrent participation in another investigational treatment clinical trial * Concurrent participation in supportive care trials or non-treatment trials (e.g., quality of life or laboratory analysis studies) allowed * No concurrent vitamins, antioxidants, herbal preparations, or supplements, except for a single-tablet multivitamin
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Alvocidib Hydrochloride
    2. Drug: Oxaliplatin
    label
    Part A (alvocidib and oxaliplatin)
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: Alvocidib Hydrochloride
    2. Drug: Fluorouracil
    3. Drug: Leucovorin Calcium
    4. Drug: Oxaliplatin
    label
    Part B (alvocidib and FOLFOX)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Part A (alvocidib and oxaliplatin)
    2. Part B (alvocidib and FOLFOX)
    description
    Given IV
    name
    Alvocidib Hydrochloride
    other Names
    1. 4H-1-Benzopyran-4-one, 2-(2-chlorophenyl)-5, 7-dihydroxy-8-(3-hydroxy-1-methyl-4-piperidinyl)-, hydrochloride, (-)-cis-
    2. Flavopiridol Hydrochloride
    3. HL-275
    4. HMR 1275
    5. L-86-8275
    6. L-868275
    7. MDL 107,826A
    8. MDL-107826A
    type
    DRUG
  2. arm Group Labels
    1. Part B (alvocidib and FOLFOX)
    description
    Given IV
    name
    Fluorouracil
    other Names
    1. 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
    2. 5-Fluorouracil
    3. 5-Fluracil
    4. 5-FU
    5. AccuSite
    6. Actino-Hermal
    7. Adrucil
    8. Arumel
    9. Cytosafe
    10. Efudex
    11. Efurix
    12. Fiverocil
    type
    DRUG
  3. arm Group Labels
    1. Part B (alvocidib and FOLFOX)
    description
    Given IV
    name
    Leucovorin Calcium
    other Names
    1. Adinepar
    2. Calcifolin
    3. Calcium (6S)-Folinate
    4. Calcium Folinate
    5. Calcium Leucovorin
    6. Calfolex
    7. Calinat
    8. Cehafolin
    9. Citofolin
    10. Citrec
    11. Citrovorum Factor
    12. Cromatonbic Folinico
    type
    DRUG
  4. arm Group Labels
    1. Part A (alvocidib and oxaliplatin)
    2. Part B (alvocidib and FOLFOX)
    description
    Given IV
    name
    Oxaliplatin
    other Names
    1. 1-OHP
    2. Dacotin
    3. Dacplat
    4. Diaminocyclohexane Oxalatoplatinum
    5. Eloxatin
    6. Eloxatine
    7. JM-83
    8. Oxalatoplatin
    9. Oxalatoplatinum
    10. RP 54780
    11. RP-54780
    12. SR-96669
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
36
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    graded using the NCI CTCAE version 4.0.See adverse event section
    measure
    Toxicity
    time Frame
    Up to 4 years
  2. measure
    Progression-free Survival
    time Frame
    From treatment start until first documented progression or death, assessed up to 4 years
  3. measure
    Time to Tumor Response
    time Frame
    From treatment start until first documented CR or PR, assessed up to 4 years
primary Outcomes
  1. description
    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
    measure
    Objective Response Rate
    time Frame
    Within 3 courses of treatment
Full study description
brief Summary
This phase II trial is studying alvocidib and oxaliplatin to see how well they work when given with or without fluorouracil and leucovorin calcium in treating patients with relapsed or refractory germ cell tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin, fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving alvocidib together with oxaliplatin with or without fluorouracil and leucovorin calcium may kill more tumor cells.
detailed Description
PRIMARY OBJECTIVES: I. To evaluate the antitumor efficacy of the combination of flavopiridol and oxaliplatin with or without 5-FU and leucovorin in patients with relapsed or refractory GCT. The necessity of 5-FU and leucovorin to the combination will also be indirectly tested in this study. SECONDARY OBJECTIVES: I. To further evaluate the safety of flavopiridol in combination with oxaliplatin with or without 5-fluorouracil and leucovorin in patients with refractory or relapsed GCT. II. To evaluate the time to tumor response (TTR) and progression-free survival for patients with refractory or relapsed GCT treated with flavopiridol in combination with oxaliplatin with or without 5-fluorouracil and leucovorin. III. To explore the association between treatment response and p21, p53 and apoptotic markers. OUTLINE: Patients are initially enrolled in part A (closed to accrual as of 11/15/2010). Depending on response to treatment, additional patients may be enrolled in part B. PART A (alvocidib and oxaliplatin) (closed to accrual as of 11/15/2010): 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. PART B (alvocidib and FOLFOX): 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. Tumor tissue samples may be collected periodically for further laboratory analysis. After completion of study treatment, patients are followed up every 4-8 weeks.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice