Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:- Metastatic or locally advanced (unresectable) colorectal cancer with histological confirmation of adenocarcinoma (patients with or without measurable disease by imaging are eligible) - No prior systemic chemotherapy for metastatic disease; subjects who received adjuvant therapy with FOLFOX and at the time of recurrence are at least 6 months away from last chemotherapy are eligible for this study - At the time of randomization to maintenance therapy only patients who didn't progress by Response Evaluation Criteria in Solid Tumors (RECIST) criteria are eligible; patients with complete response (CR) and those who are candidates for resection will not be eligible for randomization to maintenance therapy, subjects who undergo surgery potentially have curable disease with defined duration of treatment and use of EGFR in the adjuvant setting is deemed to be detrimental in these population; likelihood of achieving CR is low and standard of care in this unique patient population is not well defined - Provide written informed consent - RAS wild‐type tumor - Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only - Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 or 1 - Total serum bilirubin =< institutional upper limit of normal (ULN) - Absolute neutrophil count (ANC) >= 1500/mm^3 - Platelet count >= 100,000/mm^3 - Hemoglobin >= 9.0 g/dL (hemoglobin may be supported by transfusion) - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) - Creatinine within institutional limits of normal OR creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal - Magnesium >= lower limit of normal - Willing to provide tissue and blood samples for mandatory correlative and research purposes
Exclusion Criteria:- Patients who are candidates for upfront metastasectomy (defined as those with limited liver metastatic disease) are not eligible for this study; the candidacy for resectability can be determined by the treating physician and or local surgeon; in ambiguous situations, please discuss the case with the principle investigator (PI) - Known or suspected brain or central nervous system (CNS) metastases - Active, uncontrolled infection, including hepatitis B, hepatitis C - Patients with history of interstitial lung disease/pulmonary fibrosis - Concurrent anti‐cancer therapy, including chemotherapy agents, targeted agents, or biological agents not otherwise specified in this protocol - Radiation therapy =< 2 weeks prior to randomization - Any of the following - Pregnant or nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception - Co‐morbid systemic illnesses or other severe concurrent disease, history of any psychiatric or addictive disorder, or laboratory abnormality, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens - Patients known to be human immunodeficiency virus (HIV) positive - Uncontrolled intercurrent illness whom in the opinion of the investigator, may increase the risks associated with study participation or study treatment, or may interfere with the conduct of the study or the interpretation of the study results - Receiving any other investigational agent, which would be considered as a treatment for the primary neoplasm - Other active malignancy =< 3 years prior to registration; exceptions are: nonmelanoma skin cancer or carcinoma‐in‐situ of the cervix that has been treated - History of prior malignancy for which patient is receiving other specific treatment for their cancer - History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Southern California|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Afsaneh Barzi, MD|
|Principal Investigator Affiliation||University of Southern California|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Colorectal Adenocarcinoma, RAS Wild Type, Stage III Colorectal Cancer AJCC v7, Stage IIIA Colorectal Cancer AJCC v7, Stage IIIB Colorectal Cancer AJCC v7, Stage IIIC Colorectal Cancer AJCC v7, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7|
- I. To compare the duration of progression free survival 1 (PFS1) in patients with RAS wild type who have received induction leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) + panitumumab and not progressed at 6 cycles and randomized to maintenance therapy with fluorouracil (5FU) based therapy with or without panitumumab.
- I. To compare the response rate (RR) in patients with RAS wild type who are randomized to maintenance therapy with 5FU based therapy to those randomized to 5FU based therapy with panitumumab.
- I. Progress free survival 2 (PFS2).
- II. To assess the adverse event (AE) profile and safety of the proposed treatment in this population.
- III. To assess and compare the overall survival (OS) between the two treatment groups.
- IV. To compare the quality of life (QOL) as measured by health state index (HIS) between patients who achieve partial response (PR) versus (vs.#46;) those who progress and those who have stable disease during the induction phase.
- V. To compare the QOL as measured by HSI between the two groups randomized to maintenance therapy.
- VI. To assess the evolution of RAS mutation under treatment during induction phase as well as maintenance.
- VII. To explore relationship between genomic and proteomic alterations of the tumor with response and PFS to panitumumab.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.