Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer

Plain-language summary

This study evaluates the drugs EPO906 and Celecoxib (Celebrex) in patients with metastatic colorectal cancer for whom standard chemotherapy is no longer effective. It included patients who had failed 5-FU, CPT-11, and/or oxaliplatin-based chemotherapy. It was a Phase 1/Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Completed

Sponsor

University of Southern California

Intervention

EPO906, Celecoxib

Start date

10/12/2004

Estimated completion

3/23/2023

Countries

United States

Related genes

Locations

• Los Angeles, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.