Search > Colorectal Cancer
55 Participants NeededMy employer runs this trial

Intraperitoneal Paclitaxel for Colorectal Cancer

CF
Uo
Overseen ByUniversity of California Irvine Medical
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, Irvine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a phase II open-label, basket clinical trial to assess the feasibility of systemic and Intraperitoneal chemotherapy in subjects with Gastrointestinal Malignancies with Peritoneal Carcinomatosis. These are subjects who have a proven primary carcinoma of the digestive tract..

Who Is on the Research Team?

MS

Maheswari Senthil, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with cancers of the digestive tract (like colon, stomach, rectum, appendix, small bowel, or esophagus) that have spread to the lining of the abdomen. Participants must have confirmed cancer in these areas.

Inclusion Criteria

Life expectancy greater than 3 months
I have adenocarcinoma of the digestive tract not covered in other study groups.
My activity level is limited only by my cancer, not by other health problems.
See 6 more

Exclusion Criteria

I do not have any serious uncontrolled illnesses or recent major heart problems.
Pregnant or nursing patients due to potential harm to infants
Inability to comply with study and follow-up procedures as judged by Investigator
See 8 more

What Are the Treatments Tested in This Trial?

Interventions

  • Paclitaxel

Trial Overview

The study is testing two schedules of paclitaxel chemotherapy: one given every 2 weeks and another every 3 weeks. The drug is delivered both into a vein and directly into the abdominal cavity to see if this approach is practical and safe.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: CohtCQ3W: Cohort C Other Malignancies of the Digestive Tract (Paclitaxel Q3W)Experimental Treatment1 Intervention
Group II: CohtCQ2W: Cohort C Other Malignancies of the Digestive Tract (Paclitaxel Q2W)Experimental Treatment1 Intervention
Group III: CohtBQ3W: Cohort B Colorectal/Appendiceal Adenocarcinoma (Paclitaxel Q3W)Experimental Treatment1 Intervention
Group IV: CohtBQ2W: Cohort B Colorectal/Appendiceal Adenocarcinoma (Paclitaxel Q2W)Experimental Treatment1 Intervention
Group V: CohtAQ3W: Cohort A Gastric/Esophageal Carcinoma (Paclitaxel Q3W)Experimental Treatment1 Intervention
Group VI: CohtAQ2W: Chort A Gastric/Esophageal Carcinoma (Paclitaxel Q2W)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

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