- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00066677
Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with docetaxel may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying bevacizumab and docetaxel to see how well they work compared to bevacizumab alone in treating patients with metastatic pancreatic cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- Determine the progression-free survival of patients with previously treated metastatic pancreatic adenocarcinoma treated with bevacizumab with or without docetaxel.
- Determine the objective response rate and overall survival of patients treated with these regimens.
- Determine the incidence of thromboembolic events in patients treated with these regimens.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV over 1 hour on days 1, 8, and 15.
- Arm II: Patients receive bevacizumab as in arm I. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19111-2497
- Fox Chase Cancer Center - Philadelphia
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the pancreas
- Metastatic disease
Unidimensionally measurable disease outside of the pancreas
- At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Must have received 1, and only 1, prior gemcitabine-containing regimen for metastatic disease unless disease has recurred within 6 months after treatment with neoadjuvant or adjuvant gemcitabine-containing therapy
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9.0 g/dL (transfusion allowed)
- No bleeding diathesis or coagulopathy
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- AST and ALT no greater than 1.5 times ULN
- INR no greater than ULN
- PTT no greater than ULN
Renal
- Creatinine no greater than 2.0 mg/dL
- No clinically significant renal impairment
- Urine protein:creatinine ratio ≥ 1.0
Cardiovascular
- No prior myocardial infarction
- No prior stroke
- No clinically significant cardiovascular disease
- No uncontrolled hypertension (i.e., blood pressure greater than 160/110 mm Hg on medication)
- No unstable angina
- No New York Heart Association class II-IV congestive heart failure
- No serious cardiac dysrhythmia requiring medication
- No peripheral vascular disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history or evidence of CNS disease (e.g, primary brain tumor or seizures not controlled with standard medical therapy)
- No other medical condition that would preclude study participation
- No psychiatric condition that would preclude study participation
- No other prior or concurrent malignancy that would preclude study participation
- No significant traumatic injury within the past 28 days
- No serious, nonhealing wound, ulcer, or bone fracture
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent prophylactic granulocyte or platelet growth factors
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- More than 7 days since prior fine needle aspirations or core biopsies
- More than 28 days since prior surgery (except closed biopsy or access port placement)
- More than 28 days since prior open biopsy
- No concurrent surgery
Other
- More than 4 weeks since prior experimental drug study participation
- More than 4 weeks since prior investigational drugs
- No other concurrent experimental drug study participation
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: rhuMAB-VEGF
bevacizumab 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks until disease progression, unacceptable toxicity or patient preference.
|
|
Experimentell: rhuMAB-VEGF and Docetaxel
rhuMAB-VEGF,bevacizumab: 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks docetaxel, Taxotere: 35 mg/m2 given intravenously over 1 hour on days 1, 8, and 15 of each 28 day cycle.
Treatment continued until evidence of disease progression, unacceptable toxicity, or patient preference.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Progression-free Survival
Tidsram: 4 months
|
4 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Objective Response Rate
Tidsram: 56 days
|
56 days
|
Overall Survival
Tidsram: From date of registration until the date of death, assessed up to 5 years
|
From date of registration until the date of death, assessed up to 5 years
|
Number of Participants With Thromboembolic Events
Tidsram: 93 days
|
93 days
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Steven J. Cohen, MD, Fox Chase Cancer Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Sjukdomar i det endokrina systemet
- Neoplasmer i matsmältningssystemet
- Neoplasmer i endokrina körtel
- Bukspottkörtelsjukdomar
- Pankreatiska neoplasmer
- Molekylära mekanismer för farmakologisk verkan
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Docetaxel
Andra studie-ID-nummer
- CDR0000316454
- P30CA006927 (U.S.S. NIH-anslag/kontrakt)
- FCCC-03003
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