- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01632020
Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
Pilot Study: Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
The purpose of this study is to investigate the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma.
It is hypothesized that there are independent actions of Metformin on the outcome of subjects with colorectal cancer (CRC). Also hypothesized is that metformin effects on CRC cell growth will correlate with this drug's effects on markers mentioned above, because the markers are closely related to tumor growth and metastases.
Přehled studie
Detailní popis
This is a randomized, double-blinded placebo controlled clinical investigation of the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma. Metformin is a well-tolerated drug widely prescribed for treatment of Type 2 diabetes mellitus. Preliminary studies have generated the hypothesis that metformin may have positive effects on both prevention and survival of colon cancer subjects. Clinical trials are ongoing to explore this possibility in breast cancer (NCT01101438). This investigation is the first study of Metformin in colorectal cancer (CRC) patients, and is designed to understand the mechanism of its anti-cancer actions, if any, and its interactions with biomarkers in colorectal cancer patients.
Based upon epidemiological studies, it is hypothesized that there are independent actions of Metformin on the outcome of subjects with CRC. Also hypothesized is that metformin effects on CRC cell growth will correlate with this drug's effects on markers mentioned above, because the markers are closely related to tumor growth and metastases.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Arkansas
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Little Rock, Arkansas, Spojené státy, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Spojené státy, 72205
- Central Arkansas Veterans Heathcare System
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Male or female, all races and ethnicities are eligible
- Age equal to or greater than 18 years of age
- All subjects should have a pathological/histological diagnosis of colorectal cancer.
- Clinical diagnosis of stage I, II, III or IV colon cancer or stage I, II, III or IV rectal cancer; cancer may be primary including a secondary primary
- Candidate for elective surgery(for removal of primary) or endoscopic biopsy
- ECOG Performance status of 0 - 2
- Adequate renal, liver, and bone marrow function
- Hb: (adequate for surgical intervention, with transfusion if necessary)
- WBC: (normal range)
- Platelets: (180K/cmm)
- LFTs: Normal bilirubin (< 2.0mg/dL), AST/ALT (2xULN)
- Renal function: normal creatinine
- Subjects must have signed informed consent
- Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of beginning the drug or placebo treatment. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months.
Exclusion Criteria:
- Previously diagnosed with diabetes mellitus Type 1 or Type 2.
- Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR inhibitors or having taken any of these medications during the 12 weeks prior to study participation.
- Currently taking any non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin and unable to stop such medications due to a present medical condition.
- Clinical symptoms of gastrointestinal obstruction or bleeding and consideration for immediate surgery or immediate neoadjuvant chemoradiation.
- Familial Adenomatous Polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC), Putz-Jeghers disease, ulcerative colitis, or Crohn's disease.
- Pregnant or lactating.
- History of lactic or other metabolic acidosis.
- Known hypersensitivity to Metformin.
- Uncontrolled infectious disease.
- History of Positivity for human immunodeficiency virus (HIV).
- History of congestive heart failure requiring pharmacologic treatment.
- History of excessive alcohol abuse, defined by a habitual intake of more than three drinks daily.
- Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for > 5 years, with the exception of prior CRC which has been treated and the patient has been in remission and the current primary tumor is a second CRC.
- Unable to swallow and retain oral medication.
- Mal-absorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel.
- Current use of medications for weight loss.
- Currently taking cimetidine, thiazide diuretics or cephalexin. If a patient needs some of these agents, alternative agents should be substituted.
- If the physician feels that the candidate is not suitable for the study, he/she will be excluded.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Komparátor placeba: Placebo
Placebo 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
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2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
Ostatní jména:
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Aktivní komparátor: Metformin
Metformin 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
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850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Proliferation Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy
Časové okno: 10-21 days
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10-21 days
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Mucosal Apoptotic Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy
Časové okno: 10-21 days
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10-21 days
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Rangaswamy Govindarajan, MD, University of Arkansas
- Vrchní vyšetřovatel: Frank Simmen, PhD, University of Arkansas
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- Novotvary
- Novotvary podle místa
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Gastrointestinální onemocnění
- Onemocnění tlustého střeva
- Střevní nemoci
- Střevní novotvary
- Rektální onemocnění
- Kolorektální novotvary
- Hypoglykemická činidla
- Fyziologické účinky léků
- Metformin
Další identifikační čísla studie
- 134190
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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