Is NCT07042685 recruiting in Houston, TX?

Yes, NCT07042685 is currently recruiting participants at its Houston, TX location. This metastatic colorectal cancer (crc) clinical trial is actively enrolling qualified participants.

How do I join the metastatic colorectal cancer (crc) clinical trial in Houston?

To join this clinical trial in Houston, 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 Houston 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 Cancer (CRC) Clinical Trial in Houston, TX

About This Metastatic Colorectal Cancer (CRC) Study in Houston

This Phase II clinical trial at Houston Methodist Neal Cancer Center is evaluating the safety and efficacy of combining 5-Fluorouracil (5FU) -based chemotherapy (either FOLFIRI: folinic acid, 5FU, irinotecan; or mFOLFOX6: folinic acid, 5FU, oxaliplatin) with fruquintinib as a first-line treatment for patients with locally advanced unresectable or metastatic colorectal cancer. Fifty patients will receive treatment in 28-day cycles, with fruquintinib initially dosed at 4 mg daily and potentially increased to 5 mg if no significant toxicities are observed. After six months, patients showing stable disease or better will transition to a maintenance phase with 5FU and fruquintinib, continuing until disease progression or other discontinuation criteria are met. The primary endpoint is time to progression based on RECIST v1.1 criteria, while secondary endpoints include safety, tolerability, and duration of response. The trial is being conducted across multiple Houston Methodist hospitals and is currently the only first-line CRC trial available in the system. If successful, it could offer a new therapeutic option and inform future treatment guidelines for advanced colorectal cancer.

Sponsor: The Methodist Hospital Research Institute

Who Can Participate

Inclusion Criteria

Male or female ≥18 years of age.

Written informed consent is required before performing any trial-specific tests or procedures. Signing of the informed consent form can occur outside the 28-day screening period.

Histopathologically or cytologically confirmed locally advanced unresectable or metastatic colorectal cancer. The study will include an all-comer population, meaning that patients will not be excluded based on specific molecular markers such as microsatellite instability-high (MSI-H) or B-Raf proto-oncogene mutations (BRAF mutations). However, as part of the Standard of Care, comprehensive molecular testing will be performed to assess MSI status, and other relevant biomarkers. For patients with MSI-H or BRAF mutations confirmed, treatment may be adjusted per Standard of Care practices.

Measurable disease per RECISTv1.1.

No prior systemic treatment. Patients with resected disease who later develop unresectable recurrence without prior systemic therapy remain eligible.

ECOG performance status of 0 or 1.

Life expectancy ≥6 months per treating physician's assessment.

Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of study treatment.

Patients must be able to swallow oral tablets.

Exclusion Criteria

Hematology laboratory values of:

Absolute neutrophil count ≤1500 cells/mm3

Platelets ≤100,000 cells/mm3

Hemoglobin ≤9 g/dL

White blood count ≤3000 cells/mm3.

Hepatic laboratory values of aspartate transaminase (AST) or alanine aminotransferase (ALT):

\>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or

\>2.5 × ULN if no liver metastases are present.

Serum albumin \<2.8 g/dL.

Total bilirubin \>1.7 mg/dL × ULN.

Prothrombin time (PT) or international normalized ratio (INR) \>1.5 × ULN. Note: Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible if PT and INR are within the acceptable institutional therapeutic limits.

Serum creatinine or serum urea \>1.5 × ULN.

Estimated glomerular filtration rate \<50 mL/min.

Urine dipstick or urinalysis with protein ≥2+ or 24-hour urine protein ≥1.0 g/24-h. Subjects with 1+ proteinuria must undergo a 24-hour urine collection to assess urine protein level.

Positive pregnancy test, pregnant, or breastfeeding for all women of child-bearing potential.

Per treating physician's assessment, any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study.

Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study including, but not limited to:

Bradycardia

Tachycardia

Symptomatic valvular disease

Symptomatic congestive heart failure is classified by the New York Heart Association as Class III or IV

Unstable angina pectoris.

Myocardial infarction within the past 6 months from consent.

Active bleeding diathesis.

Current complaints of persistent constipation or history of chronic constipation, untreatable bowel obstruction, or fecaloma within the past 6 months from consent.

Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or other systemic immunosuppressive agents. Topical or nasal corticosteroids are allowed.

Known history and/or uncontrolled hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2.

History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption.

History of malignancy or active treatment for malignancy other than CRC (i.e., radiation or chemotherapy, including monoclonal antibodies) within 5 years. Note: Patients with squamous or basal cell carcinomas of the skin, carcinomas in situ of the cervix or uterus, ductal breast cancer in situ, resected low-grade prostate cancer, or other malignancies that in the opinion of the investigator are considered cured may participate.

Receipt of live, attenuated vaccine (e.g., intranasal influenza, measles, mumps, rubella, varicella) or close contact with someone who has received a live, attenuated vaccine within the past 1 month from consent. Note: Influenza vaccine will be allowed if administered \>21 days.

Receipt of any investigational agent or study treatment within the past 30 days from consent for a condition other than CRC.

Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within the past 3 months from consent for a condition other than CRC.

Uncontrolled hypertension

Active infection requiring treatment

Recent history of major surgery

Thromboembolic events during the past 6 months

Adults unable to consent

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 Houston?

Yes, this clinical trial (NCT07042685) has an active research site in Houston, 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 Cancer (CRC) Treatment Options in Houston, TX

If you're searching for metastatic colorectal cancer (crc) treatment options in Houston, TX, this clinical trial (NCT07042685) 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 Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic colorectal cancer (crc) 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 cancer (crc) clinical trials near you to find additional studies recruiting in your area.

Metastatic Colorectal Cancer (CRC) Clinical Trial in Houston, TX

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