- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00052507
Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer
RATIONALE: Bortezomib may interfere with the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have metastatic or recurrent colorectal cancer.
Studieöversikt
Detaljerad beskrivning
OBJECTIVES:
- Determine the efficacy of bortezomib, in terms of response rate and stable disease rate, in patients with recurrent or metastatic colorectal cancer.
- Determine the toxicity of this drug in these patients.
- Determine the time to progression and response duration in patients treated with this drug.
- Determine whether there is a relationship between levels of transcription factors NF kappa B and HIF-1 alpha and clinical outcome in patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 2-4 months.
Studietyp
Fas
- Fas 2
Kontakter och platser
Studieorter
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Ontario
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Hamilton, Ontario, Kanada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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London, Ontario, Kanada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Ottawa, Ontario, Kanada, K1H 1C4
- Ottawa Regional Cancer Centre
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Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Hospital at University Health Network
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is incurable with conventional therapy
- Metastatic or recurrent disease
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
- Disease must be accessible to biopsy
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1 OR
- Karnofsky 70-100%
Life expectancy
- More than 3 months
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- AST or ALT no greater than 3 times ULN (less than 5 times ULN if liver metastases present)
Renal
- Creatinine no greater than 1.25 times UNL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled concurrent illness
- No ongoing or active infection
- No other active malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- No grade 1 or greater peripheral neuropathy due to prior chemotherapy
- No significant traumatic injury within the past 21 days
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No more than 1 line of prior chemotherapy (including any combination of fluorouracil, irinotecan, and/or oxaliplatin) for metastatic disease
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Prior adjuvant chemotherapy allowed
- No concurrent cytotoxic chemotherapy
Radiotherapy
- More than 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to measurable target lesion unless disease progression has occurred after radiotherapy
- No concurrent radiotherapy to the sole site of measurable disease
Surgery
- More than 21 days since prior major surgery
Other
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Maskning: Ingen (Open Label)
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Amit M. Oza, MD, Princess Margaret Hospital, Canada
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PMH-PHL-012
- CDR0000258488 (Registeridentifierare: PDQ (Physician Data Query))
- NCI-5890
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