- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00488982
Intermittent Chemotherapy With or Without Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Metastatic Hormone Refractory Prostate Cancer (HRPC)
A Randomized Phase II Study of Intermittent Chemotherapy or Intermittent Chemotherapy With Maintenance GM-CSF in Patients With Previously Untreated Hormone Refractory Prostate Cancer
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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California
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San Francisco, California, Vereinigte Staaten, 94115
- University of California, San Francisco
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02215
- Dana Farber Cancer Institute
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97239
- Oregon Health and Science University Cancer Institute
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Washington
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Seattle, Washington, Vereinigte Staaten, 98109
- University of Washington
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age over 18 years
- Histologically documented adenocarcinoma of the prostate
- Progressive metastatic prostate cancer
- Castrate levels of testosterone (<50 ng/ml) must be maintained
Prior hormonal therapy or medications :
Patients who are receiving an anti-androgen, secondary hormonal therapy (i.e. ketoconazole, aminoglutethimide, megestrol acetate, diethylstilbestrol), 5-alpha reductase inhibitor (i.e. finasteride (Proscar), dutasteride (Avodart)) or herbal prostate medication (i.e. saw palmetto, PC-SPES, PC-PLUS) must discontinue the drug by the date of initiation of chemotherapy on study
- ≥ 4 weeks since major surgery and fully recovered
- ≥ 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to ≤grade 1
- ≥ 8 weeks since the last dose of strontium or samarium
- Sexually active patients must agree to use adequate contraception
- Karnofsky Performance Status ≥ 60%
- Life expectancy >12 weeks
- Required initial laboratory values Absolute neutrophil count > 1500/ul Platelets > 100,000/ul Hemoglobin > 8.0 g/dl Creatinine ≤ 2.0 X upper limit of normal Bilirubin ≤upper limit of normal (ULN)
aspartate aminotransferase (AST) / alanine aminotransferase (ALT) / alkaline phosphatase: AST AND ALT AND alkaline phosphatase must be within the range allowing for eligibility In determining eligibility, the more abnormal of the 2 values (AST or ALT should be used. An abnormal alkaline phosphatase must be attributed to liver dysfunction and not metastatic bone involvement (i.e elevated gamma-glutamyl transpeptidase (GGTP) or evidence of liver metastases)
Inclusion criteria for late enrolling patients:
- Age over 18 years
- Histologically documented adenocarcinoma of the prostate
- ≤3 cycles of prior docetaxel chemotherapy for metastatic disease permitted prior to enrollment
- Docetaxel must have been administered on an every 3 week schedule
- Each docetaxel dose must have been between 60 and 75 mg/m2
- Castrate levels of testosterone <50 ng/mL
- Daily use of other steroids (hydrocortisone, dexamethasone) instead of prednisone or no steroids, is permitted up until time of enrollment
- A Prostate-specific antigen (PSA) level must have been documented within 6 weeks of initiating docetaxel chemotherapy
Exclusion Criteria:
- Prior systemic chemotherapy for prostate cancer, other than q 3-week docetaxel/prednisone. Prior neoadjuvant or adjuvant chemotherapy is permitted if there was no evidence of disease relapse within 12 months of the last dose of chemotherapy.
- >3 cycles of q3 week docetaxel/prednisone chemotherapy has already been administered to the patient
- Peripheral neuropathy >grade 1
- Prior immunotherapy including systemic GM-CSF or vaccines utilizing GM-CSF; prior G-CSF support of chemotherapy-related neutropenia is permitted
- Prior biologic agents (i.e.,anti-angiogenic agents, anti-Epithelial Growth Factor Receptor (EGFR) inhibitors)≤ 4 weeks prior to registration
- More than two prior therapies with an investigational agent, completed ≤ 4 weeks prior to enrollment (no prior immunotherapeutics are allowed)
- Myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (NYHA Class III or higher) or uncontrolled cardiac arrhythmia
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 will be excluded
- Poorly controlled diabetes (fasting blood glucose >250) despite optimization of medical therapy
Exclusion criteria for late enrolling patients:
- Prior immunotherapy including systemic GM-CSF or vaccines utilizing GM-CSF; prior G-CSF support for chemotherapy-related neutropenia is permitted
- Delay of ≥6 weeks between any 2 chemotherapy cycles prior to enrollment on study
- Cumulative delays ≥8 weeks between chemotherapy cycles prior to enrollment on study
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Docetaxel + Observation
Intermittent docetaxel/prednisone with no maintenance therapy: Patients will discontinue docetaxel/prednisone and undergo observation until disease progression at which time they will re-initiate docetaxel/prednisone. Six cycles of docetaxel/prednisone will again be administered before subsequent discontinuation of chemotherapy
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Docetaxel 75mg/m2 every 21 days
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Experimental: Docetaxel + GM-CSF
Intermittent docetaxel/prednisone with maintenance GM-CSF therapy: Patients will discontinue docetaxel/prednisone and will receive maintenance GM-CSF until disease progression at which time, they will discontinue GM-CSF and resume docetaxel/prednisone. Six cycles of docetaxel/prednisone will again be administered before discontinuation of chemotherapy and GM-CSF therapy is re-initiated.
GM-CSF dose/schedule will be as previously described (250 mcg/m2 SQ daily, days 15-28 q28 days)
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Docetaxel 75mg/m2 every 21 days and GM-CSF 250mcg/m2 SQ days 15-28
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time to Progression
Zeitfenster: Up to 7 years
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The Kaplan-Meier product limit method with 95% confidence intervals will be used to estimate the median time to disease progression during initial course of randomized treatment
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Up to 7 years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Overall Survival
Zeitfenster: Up to 7 years
|
The Kaplan-Meier product limit method will be used to estimate the median overall survival
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Up to 7 years
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Number of Participants With PSA Response to Successive Series of Chemotherapy
Zeitfenster: Up to 6 years
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PSA partial response is defined by at least a 50% decline from PSA value from the baseline measurement to 12 weeks of protocol therapy.
The decline must be confirmed by a second PSA value obtained 4 or more weeks later For those patients whose PSA have decreased but has not reached response criteria defined above, progressive disease is defined as 25% increase over the nadir PSA value provided that the increase is at least 5ng/mL and is confirmed.
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Up to 6 years
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Cumulative Duration of Time on and Off Docetaxel-based Therapy
Zeitfenster: Up to 7 years
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Median percentage of time will be calculated to summarize the total duration of chemotherapy and amount of docetaxel/prednisone administered while the patient is on study.
The same results will be tabulated for each.
For the on-chemotherapy period: will be estimated from the date of starting protocol therapy; if a patient received docetaxel on day 2 of a cycle, he will be considered to have received a full 21 days on therapy.
For the off-chemotherapy period: will be calculated from the date of starting the observation or GM-CSF period to the date of resuming chemotherapy
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Up to 7 years
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Eric Small, MD, University of California, San Francisco
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 055511
- NCI-2011-01269 (Registrierungskennung: NCI Clinical Trials Reporting Program (CTRP))
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
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