- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00032110
Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
A Phase II Study of OSI-774 in Metastatic Colorectal Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. Determine the efficacy of erlotinib, in terms of response rate and duration of stable disease, in patients with recurrent or metastatic colorectal cancer.
II. Determine the toxicity of this drug in these patients. III. Determine the time to progression and response duration in patients treated with this drug.
IV. Determine the relationships between clinical, pharmacokinetic, and pharmacodynamic effects of this drug in these patients.
V. Correlate baseline and post-treatment levels of epidermal growth factor receptor, its downstream signaling components, markers of angiogenesis, and apoptosis in tumor and skin biopsies with clinical outcome in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after CR is confirmed.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 4-8 months.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital Phase 2 Consortium
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not curable with conventional therapy
- Recurrent or metastatic disease
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
- Target lesion must not be in a previously irradiated field unless progression of this lesion has been documented
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 3 months
- WBC at least 1,500/mm^3
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- AST or ALT no greater than 3 times ULN (5 times ULN if liver metastases present)
- Creatinine no greater than 1.25 times ULN
- Creatinine clearance at least 50 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
- No active peptic ulcer disease
- No unresolved complete or subacute bowel obstruction
- No severe enteropathy that would interfere with absorption of study drug
No abnormalities of the cornea:
- Dry eye syndrome or Sjogren's syndrome
- Congenital abnormality (e.g., Fuch's dystrophy)
- Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
- Abnormal corneal sensitivity test (Schirmer test or similar tear production test)
- No significant traumatic injury within the past 21 days
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study
- No other concurrent uncontrolled illness that would preclude study
- No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No more than 1 prior chemotherapy regimen for metastatic disease with either fluorouracil (5-FU) and oxaliplatin or 5-FU and a topoisomerase inhibitor (e.g., irinotecan), OR 5-FU (or other single-agent fluoropyrimidine, such as capecitabine) followed by irinotecan for advanced disease
- Prior adjuvant chemotherapy allowed
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- At least 3 weeks since prior major surgery
- No prior surgical procedures affecting absorption
- No prior epidermal growth factor receptor-targeting therapy
- No other concurrent investigational therapies
- No other concurrent anticancer therapy
- No concurrent combination anti-retroviral therapy for HIV-positive patients
No concurrent warfarin
- Low molecular weight heparin allowed
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily.
Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with a CR receive 2 additional courses after CR is confirmed.
|
Korrelative undersøgelser
Korrelative undersøgelser
Andre navne:
Gives oralt
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Objective response or disease stabilization
Tidsramme: Up to 5 years
|
Up to 5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Molecular changes with therapy
Tidsramme: Up to 5 years
|
Will be examined using logistic regression or Fisher's exact tests as appropriate.
|
Up to 5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Amit Oza, Princess Margaret Hospital Phase 2 Consortium
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Patologiske processer
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Sygdomsegenskaber
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Tilbagevenden
- Adenocarcinom
- Rektale neoplasmer
- Colon neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Erlotinib hydrochlorid
Andre undersøgelses-id-numre
- NCI-2012-02459 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- N01CM17107 (U.S. NIH-bevilling/kontrakt)
- CDR0000069258
- PHL-003 (Anden identifikator: Princess Margaret Hospital Phase 2 Consortium)
- NCI-5378
- 5378 (Anden identifikator: CTEP)
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