Metastatik Kolorektal Kanser Hastalarında Celebrex ve EPO906 Çalışması (Faz I/II)

Sade dilde özet

Bu çalışma, standart kemoterapinin fayda sağlamadığı metastatik kolorektal kanser (metastatic colorectal cancer) hastalarında EPO906 ve Celecoxib (Celebrex) ilaçlarını inceliyor. Daha önce 5-FU, CPT-11 ve/veya oksaliplatin tedavisi başarısız olmuş hastalar dahil edilmiştir. Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

PHASE1/PHASE2

Durum

Tamamlandı

Sponsor

University of Southern California

Müdahale

EPO906, Celecoxib

Başlangıç

12.10.2004

Tahmini bitiş

23.03.2023

Ülkeler

United States

İlgili genler

Merkezler

• Los Angeles, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Histologically confirmed metastatic adenocarcinoma of the colon or rectum for which no further standard chemotherapy is considered to be effective. Patients must have failed 5-FU, CPT-11 and/or oxaliplatin based chemotherapy.
* SWOG performance status 0-1
* ANC\>1000, platelets \>100,000.
* Total bilirubin \< 2 x upper limit of normal. Transaminase (AST and/or ALT) \< 2 x upper limit of normal or \< 5 x upper limit of normal in patients with liver metastasis.
* Serum creatinine \< 1.25 x institutional upper limit of normal.
* Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.

Exclusion Criteria:

* Patient has received any other investigational agent within 28 days of first day of study drug dosing.
* History of another malignancy within 3 years prior to study entry, except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ.
* Patient has another severe and/or life-threatening medical disease.
* Patient has an acute or known chronic liver or kidney disease (e.g., chronic active hepatitis, cirrhosis, chronic renal insufficiency).
* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
* Patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-C or any antibody therapy)
* Patients with symptomatic brain metastasis.
* Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (e.g. congestive heart failure, myocardial infarction within 6 months of study)
* Medical, social or psychological factors interfering with compliance.
* Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry.
* Patients taking Coumadin® or other agents containing warfarin, with the exception of low dose Coumadin® (1 mg or less) administered prophylactically for maintenance of in-dwelling lines or ports.
* Any peripheral neuropathy \> Grade 1.
* Patients with unresolved diarrhea \> Grade 1.
* Patients may not have a history of an allergy to sulfonamide drugs.
* Patients may not have active peptic ulcer disease or other contraindications to chronic NSAID use or aspirin use.
* Patients with lactose intolerance.
* Patients taking full-dose NSAIDs, including aspirin, regularly for any reason (e.g., arthritis,history of TIA or myocardial infarction). Patients taking cardiac preventive dose ASA (\<81mg daily) are eligible. Patients should stop taking any other NSAIDs 14 days prior to receiving first dose of Celecoxib.
* Patients with hypersensitivity to COX-2 inhibitors, NSAIDS or salycilate.
* Patients taking fluconazole or lithium.