Is NCT06269978 recruiting in Dallas, TX?

Yes, NCT06269978 is currently recruiting participants at its Dallas, TX location. This metastatic colorectal carcinoma clinical trial is actively enrolling qualified participants.

How do I join the metastatic colorectal carcinoma clinical trial in Dallas?

To join this clinical trial in Dallas, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Dallas clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metastatic Colorectal Carcinoma Clinical Trial in Dallas, TX

About This Metastatic Colorectal Carcinoma Study in Dallas

This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer.

Sponsor: Arjun Mittra

Who Can Participate

Inclusion Criteria

Age \>= 18 years

Biopsy proven colorectal cancer with peritoneal metastasis. Patients with extraperitoneal metastases will not be eligible. Patients with involvement of intra-abdominal lymph nodes may be eligible at the discretion of the treating physician

Primary colorectal cancer may either be left in place or have been resected prior to study enrollment

Patients are allowed to have received prior colorectal cancer-directed systemic therapy.

Not previously undergone cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at the time of enrollment

Absolute neutrophil count (ANC) ≥ 1,500 /mcL

Platelets ≥ 100,000 / mcL

Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL/min for patient with creatinine levels \> 1.5 x institutional ULN (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\])

Creatinine clearance should be calculated per institutional standard

Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patient with total bilirubin levels \> 1.5 ULN

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN

Both values must be in the specified range

Albumin \>= 2.5 g/dL

International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Patients on anticoagulation or antiplatelet agents may be enrolled at the discretion of the treating physician, provided these can be safely held as needed for surgical procedures

Anticipated life expectancy of ≥ 6 months

Willing to comply with study procedures

Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study and at least 9 months after the last dose of study medication

For female patients of childbearing potential, a negative pregnancy test is required at or within 7 days prior to enrollment

Be willing and able to understand and sign the written informed consent document

Be willing to undergo two diagnostic laparoscopies with tumor biopsy tissue. Patients must consent to on-treatment biopsies prior to initiation of clinical trial

Be willing to provide peripheral blood and peritoneal samples for correlative studies

Exclusion Criteria

Patients who are receiving any other investigational drugs

Evidence of metastatic disease other than peritoneum based on standard of care (SOC) imaging

Patients with primary mucinous appendiceal tumors will not be eligible. These tumors often produce mucin, which may affect the penetration of IP chemotherapy. Patients with non-mucinous appendiceal adenocarcinomas will be eligible.

Patients with \>= grade 2 peripheral neuropathy

Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, active bleeding diatheses, and psychiatric illness/social situations that would limit compliance with study requirements

Major surgical procedure or significant traumatic injury less than 3 weeks or those who receive minor surgical procedures within 1 week from first dose of study drug administration

Known active chronic infections - uncontrolled human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), known active (i.e., with detectable polymerase chain reaction \[PCR\]) hepatitis B or C

Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis

Pregnancy or breastfeeding

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating physician

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Dallas?

Yes, this clinical trial (NCT06269978) has an active research site in Dallas, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Colorectal Carcinoma Treatment Options in Dallas, TX

If you're searching for metastatic colorectal carcinoma treatment options in Dallas, TX, this clinical trial (NCT06269978) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Dallas research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic colorectal carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic colorectal carcinoma clinical trials near you to find additional studies recruiting in your area.

Metastatic Colorectal Carcinoma Clinical Trial in Dallas, TX

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