- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00072566
Bevacizumab and Low-Dose Cyclophosphamide in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Phase II Clinical Trial of Bevacizumab (NSC 704865) and Low Dose Oral Cyclophosphamide in Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES: Primary I. Determine the time to progression in patients with recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab and low-dose cyclophosphamide.
Secondary I. Determine the response rate in patients treated with this regimen. II. Determine the toxicity of this regimen in these patients. III. Determine molecular correlates for response and outcomes in patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 1-2 years.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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-
California
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Duarte, California, Vereinigte Staaten, 91010
- City of Hope Comprehensive Cancer Center
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer
Unidimensionally measurable disease
- Previously irradiated indicator lesions must have progressed after radiotherapy
- Received a platinum-containing regimen for primary disease
No more than 2 prior chemotherapy regimens for recurrent disease
- Must have received prior platinum-based chemotherapy for recurrent disease if it has been > 12 months since treatment for primary disease (except if hypersensitivity to platinum has developed)
- Rechallenge with the same platinum-based regimen is considered 1 prior regimen
- No history or clinical evidence of CNS disease, including primary brain tumor
- No brain metastases
- Performance status - SWOG 0-2
- At least 3 months
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No bleeding diathesis
- No coagulopathy
- Bilirubin no greater than 1.5 times normal
- ALT or AST no greater than 3 times upper limit of normal
- INR less than 1.5 (for patients receiving warfarin)
- Creatinine no greater than 1.5 times normal
- No proteinuria (less than 1+)
- Proteinuria less than 500 mg/24-hour urine collection
- No prior deep vein thrombosis
- No prior stroke
- No clinically significant cardiovascular disease
None of the following within the past year:
- Uncontrolled hypertension
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Grade II or greater peripheral vascular disease
None of the following within the past 6 months:
- Unstable angina
- Myocardial infarction
- Transient ischemic attack
- Cerebrovascular accident
- Other arterial thromboembolic event
- No clinically significant peripheral artery disease
- No active infection requiring parenteral antibiotics
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No serious, non-healing wound, ulcer, or bone fracture
- No significant traumatic injury within the past 28 days
- No seizures not controlled with standard medical therapy
No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- All prior invasive malignancies must be in complete remission
- No other concurrent medical, psychological, or social condition that would preclude study participation
- No prior antiangiogenesis agents
- See Disease Characteristics
- Recovered from prior chemotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- More than 28 days since prior major surgical procedure or open biopsy and recovered
- At least 3 weeks since prior therapy directed at the malignancy
No recent or concurrent full-dose anticoagulants or thrombolytic agents
- Anticoagulants to maintain patency of preexisting, permanent indwelling IV catheters allowed
- No concurrent chronic daily aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Treatment (bevacizumab, cyclophosphamide)
Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses.
Patients also receive low-dose oral cyclophosphamide on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Korrelative Studien
Gegeben IV
Andere Namen:
PO gegeben
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Median Time to Progression
Zeitfenster: Up to 3 years
|
Time from treatment initiation to disease progresion calculated using the method of Kaplan-Meier.
RECIST v1.0 was used to evaluate response.
Progression was defined as a 20% or greater increase in the sums of the longest dimensions of target lesions, or the appearance of new lesions within 8 weeks of study entry.
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Up to 3 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Response Rate Based on the RECIST
Zeitfenster: Up to 3 years
|
Percentage of patients with a confirmed partial or complete response using RECIST v1.0 criteria.
Complete response was defined as the disapperance of all target and nontarget lesions, no evidence of new lesions and normalization of CA-125; Partial response was defined as a 30% or greater reduction in the sum of the longest dimensions of all target lesions and no unequivocal progression of nontarget lesions, lasting at least 4 weeks.
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Up to 3 years
|
Median Overall Survival
Zeitfenster: Time from first day of treatment to time of death due to any cause, assessed up to 3 years
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Calculated using the method of Kaplan-Meier.
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Time from first day of treatment to time of death due to any cause, assessed up to 3 years
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Agustin Garcia, City of Hope Comprehensive Cancer Center
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 (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Neubildungen nach histologischem Typ
- Neubildungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Neubildungen, Drüsen und Epithelien
- Genitale Neubildungen, weiblich
- Erkrankungen des endokrinen Systems
- Krankheitsattribute
- Eierstockerkrankungen
- Adnexerkrankungen
- Gonadenstörungen
- Neoplasmen der endokrinen Drüse
- Karzinom
- Wiederauftreten
- Eierstocktumoren
- Karzinom, Eierstockepithel
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antirheumatika
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Antineoplastische Mittel, alkylierend
- Alkylierungsmittel
- Myeloablative Agonisten
- Angiogenese-Inhibitoren
- Angiogenese-modulierende Mittel
- Wuchsstoffe
- Wachstumshemmer
- Cyclophosphamid
- Antikörper
- Immunglobuline
- Bevacizumab
- Antikörper, monoklonal
- Antineoplastische Mittel, immunologische
- Immunglobulin G
- Endotheliale Wachstumsfaktoren
Andere Studien-ID-Nummern
- NCI-2012-02562 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- P30CA033572 (US NIH Stipendium/Vertrag)
- N01CM17101 (US NIH Stipendium/Vertrag)
- NCI-5789
- CHNMC-PHII-45
- CDR0000340522
- CCC-PHII-45
- PHII-45 (Andere Kennung: City of Hope Comprehensive Cancer Center)
- 5789 (Andere Kennung: CTEP)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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