Is NCT07487168 recruiting in Tampa, FL?

Yes, NCT07487168 is currently recruiting participants at its Tampa, FL location. This peritoneal carcinomatosis clinical trial is actively enrolling qualified participants.

How do I join the peritoneal carcinomatosis clinical trial in Tampa?

To join this clinical trial in Tampa, 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 Tampa 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.

Peritoneal Carcinomatosis Clinical Trial in Tampa, FL

About This Peritoneal Carcinomatosis Study in Tampa

This single-center, Phase 1 dose-escalation study will evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of pressurized intraperitoneal aerosol chemotherapy with mitomycin C (PIPAC-MMC) for patients with unresectable peritoneal carcinomatosis from gastrointestinal primaries (colorectal, high-grade appendiceal, or small bowel). Up to three PIPAC procedures are planned at 8-week intervals while patients continue 5-fluorouracil/leucovorin (5-FU/LV) between procedures. The trial uses a Bayesian optimal interval (BOIN) design to determine dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD). Pharmacokinetics (PK), pharmacodynamics (PD), and quality of life (QoL) will be assessed.

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Who Can Participate

Inclusion Criteria

Participants must have histologically confirmed peritoneal disease from colorectal, small bowel, or high grade appendiceal adenocarcinoma. High grade appendiceal cancers include moderate or poorly differentiated mucinous or non-mucinous adenocarcinoma, signet ring cell adenocarcinoma, or goblet cell adenocarcinoma. This can be established by image guided biopsy, diagnostic laparoscopy, or previous surgery.

Patients must be ineligible for CRS/HIPEC through one of the following criteria: a) PCI score ≥16. b) Inability to achieve complete cytoreduction due to extent of disease. c) Significant small bowel involvement precluding a complete CRS. d) Unresectable disease in porta hepatis, pelvic side wall or other critical structure. e) Patients who decline invasive cytoreduction.

Participants must be 18 years of age or older.

Participants must have completed at least 4 months of first-line systemic therapy (5-FU based approach with or without biologic therapy).

Participants must have Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.

Participants must have adequate organ and marrow function as defined below: a) absolute neutrophil count ≥1500/mcL. b) platelets ≥100,000/mcL. c) total bilirubin ≤ institutional upper limit of normal (ULN). d) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN. e) creatinine ≤ 1.5 institutional ULN. or f) glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2.

Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should undergo a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification (see Appendix C). To be eligible for this trial, participants should be class 2B or better.

MMC is a known teratogen, for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration. For women of child-bearing potential a negative urine pregnancy test is required on the morning of surgery.

Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Participants who have received targeted therapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks for VEGF inhibitors, nitrosoureas or mitomycin C) prior to entering the study.

Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1), except for alopecia and chemotherapy induced peripheral neuropathy \< 2.

Patients with extensive metastatic liver disease (\>50% liver volume) are excluded from the trial as are patients with brain metastases. Patients with non-peritoneal metastatic disease are otherwise eligible provided they meet the survival expectations of \>6 months.

Patients with brain metastases are excluded

Patients with bowel obstruction or need for nutritional support (i.e., TPN or tube feeds).

Participants who are receiving any other investigational agents or enrolled on other research protocols that may interfere with compliance with requirements of the study.

History of allergic reactions or poor tolerance attributed to compounds of similar chemical or biologic composition to MMC, fluoropyrimidines, or anesthesia medications.

Participants with uncontrolled intercurrent illnesses.

Participants with psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant women are excluded from this study because MMC is an antibiotic alkylating antineoplastic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MMC, breastfeeding should be discontinued if the mother is treated with MMC.

Inability to safely perform laparoscopy due to previously noted adhesions or extensive prior surgery which the treating surgeon feels would exclude safe abdominal access.

Life expectancy less than 6 months.

Patients with history of thromboembolic complications that cannot discontinue for the perioperative duration.

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 Tampa?

Yes, this clinical trial (NCT07487168) has an active research site in Tampa, FL 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.

Peritoneal Carcinomatosis Treatment Options in Tampa, FL

If you're searching for peritoneal carcinomatosis treatment options in Tampa, FL, this clinical trial (NCT07487168) 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 Tampa research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced peritoneal carcinomatosis 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 peritoneal carcinomatosis clinical trials near you to find additional studies recruiting in your area.

Peritoneal Carcinomatosis Clinical Trial in Tampa, FL

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