Ph II Intraperitoneal Paclitaxel + System Therapy in GI Ca w/Peritoneal Carcinomatosis (STOPGAP-B)
Phase II Basket Trial of Intraperitoneal Paclitaxel Plus Systemic Therapy in Gastrointestinal Malignancies With Peritoneal Carcinomatosis (STOPGAP - B)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This phase 2 study tests whether paclitaxel chemotherapy given into the belly can be used with cancer treatment that works throughout the body. It is for adults with cancer of the digestive tract that has spread to the lining inside the belly.
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..
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have a confirmed digestive tract adenocarcinoma, a cancer that starts in gland cells, in one of the study groups below.
- Group A: Stomach cancer or cancer where the stomach meets the food pipe, with spread to the belly lining that developed later after surgery to remove stomach cancer. Spread outside the belly lining is allowed.
- Group B: Colon, rectal, or appendix cancer with spread to the belly lining. Spread outside the belly lining is allowed. Group C: Other digestive tract cancers with spread to the belly lining, such as small bowel, liver, or bile duct cancer.
- Spread to the belly lining must be found through fluid testing, scans, or surgery.
- Be at least 18 years old and expected to live more than 3 months.
- Be able to do self-care and be up and about at least half the day. If activity is limited to this level, it must be due to cancer, not other health problems.
- Meet the study's blood cell count, liver, kidney, and blood protein test requirements.
- Be able to understand and sign the consent form.
Who can't join
- For Group B: A study surgeon decides within 4 weeks before joining that surgery can remove the belly lining tumors without cancer treatment throughout the body first.
- Have a blocked small or large bowel. A blockage at the stomach outlet caused by the main cancer is allowed.
- Have an uncontrolled illness, such as an active infection, heart failure with symptoms, unstable chest pain, or an abnormal heartbeat; a stroke, mini-stroke, heart attack, or other blood-flow problem within 3 months before treatment; or a known history of active tuberculosis (TB).
- Have had another primary cancer within 3 years, except non-melanoma skin cancer, early prostate cancer, or very early cervical cancer cured without treatment that works throughout the body.
- Have had repeated chemotherapy treatments inside the belly. One heated chemotherapy treatment during tumor-removal surgery is allowed. Prior surgery that makes a belly exam with a camera or placement of a treatment tube unsafe also excludes you.
- Be pregnant or breastfeeding, or be unwilling to use birth control or avoid sex before joining, during the study, and for 90 days after treatment. Report any possible pregnancy to the treating doctor right away.
- Be unable to follow study treatment and follow-up steps.
- Have another condition, treatment, or test result that the study doctor thinks could affect the results, prevent full participation, or make joining unsafe.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Cohort A: Patients must have histologically or cytologically confirmed primary gastric or gastroesophageal adenocarcinoma with a clinical diagnosis of metachronous PC with a history of prior gastric cancer resection. Extraperitoneal metastases are allowed. * Cohort B: Patients must have histologically or cytologically confirmed primary colorectal or appendiceal adenocarcinoma with PC . Extraperitoneal metastases are allowed. Patients with PC amenable to cytoreductive surgery (CRS) without the need for upfront systemic therapy as determined by a peritoneal malignancy surgeon within 4 weeks prior to enrollment are excluded. * Cohort C: Patients must have adenocarcinomas of the digestive tract with PC not included in Cohorts A and B (including but not limited to carcinomas of the small bowel and hepatobiliary tract). * Must have peritoneal cytology positive disease or peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy * Age ≥ 18 * Performance status: ECOG performance status ≤ 2 (Appendix A) . ECOG 2 allowed if attributed to malignancy (rather than comorbidities) * Life expectancy of greater than 3 months * Adequate organ and marrow function as defined below: Leukocytes: ≥ 2,000/mcL; Absolute neutrophil count: ≥ 1,500/mcL (may receive gcsf); Platelets: ≥ 70,000/mcl (may receive TPO); Total bilirubin: within 2x of normal institutional limit; AST(SGOT)/ALT(SPGT): ≤5 X institutional upper limit of normal; Creatinine: \< 2 X institutional upper limit of normal; Hemoglobin: Hemoglobin \> 8.0 g/dL (may be transfused); Serum albumin: ≥ 2.5 g/dL * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Any evidence of small or large bowel obstruction with the exception of gastric outlet obstruction due to primary malignancy * Uncontrolled intercurrent illness including, but not limited to, the following conditions: Ongoing or active infection; Symptomatic congestive heart failure; Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic event,) within 3 months before initiation of treatment; Unstable angina pectoris; Cardiac arrhythmia * History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ and not treated with systemic therapy. * History of prior iterative intraperitonealtherapy administered either as HIPEC, PIPAC or NIPEC. Single exposure to HIPEC at the time of cytreduction is not an exclusion * Inability to comply with study and follow-up procedures as judged by the Investigator * Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. * 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, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Has an active infection requiring systemic therapy. * Prior surgery that would preclude safe diagnostic laparoscopy and port placement * Has a known history of active tuberculosis (TB; Bacillus tuberculosis). * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Study sites (1)
CA
- Chao Family Comprehensive Cancer Center, University of California, Irvine · Orange, CA 92868Maheswari Senthil, MD · Study contact · 877-827-8839 · ucstudy@uci.eduMore trials in Orange