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PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer

ConditionsClinical Stage IV Gastric Cancer AJCC v8Clinical Stage IVA Gastric Cancer AJCC v8Clinical Stage IVB Gastric Cancer AJCC v8Malignant Uterine NeoplasmMetastatic Appendix CarcinomaMetastatic Colorectal CarcinomaMetastatic Gastric CarcinomaMetastatic Malignant Neoplasm in the PeritoneumMetastatic Malignant Solid NeoplasmMetastatic Ovarian CarcinomaPathologic Stage IV Gastric Cancer AJCC v8Peritoneal CarcinomatosisPostneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8Stage IV Appendix Carcinoma AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Uterine Corpus Cancer AJCC v8Stage IVA Appendix Carcinoma AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Uterine Corpus Cancer AJCC v8Stage IVB Appendix Carcinoma AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Uterine Corpus Cancer AJCC v8Stage IVC Appendix Carcinoma AJCC v8Stage IVC Colorectal Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and/or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented informed consent of the participant and/or legally authorized representative

Patients must have histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with PC

Prior IP chemotherapy is permitted

Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2

Disqualifiers

Extra-peritoneal metastatic disease

Arm 1 (ovarian, uterine, gastric): Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones

Arm 2 (colorectal/appendiceal): Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency

Arm 2 (colorectal/appendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Cisplatin

    Drug

    Given via PIPAC

  • Doxorubicin

    Drug

    Given via PIPAC

  • Fluorouracil

    Drug

    Given IV

  • Intraperitoneal Chemotherapy

    Device

    Undergo PIPAC

  • Irinotecan

    Drug

    Given IV

  • Leucovorin

    Drug

    Given IV

  • Mitomycin

    Drug

    Given via PIPAC

  • Oxaliplatin

    Drug

    Given via PIPAC

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

49 Participants
are divided into 4 treatment groups
Group A: Arm I (PIPAC, doxorubicin, cisplatin) - Not recruitingExperimental treatment 6 interventions
Group B: Arm II (PIPAC, oxaliplatin, leucovorin, fluorouracil) - Not recruitingExperimental treatment 7 interventions
Group C: Arm III (PIPAC, mitomycin, FOLFIRI) - Not recruitingExperimental treatment 8 interventions
Group D: Arm IV (PIPAC, Cisplatin and nab-paclitaxel) - only ovarian cancer patients are eligibleExperimental treatment 0 interventions

Trial outcomes

Primary outcomes

1

Dose limiting toxicities

Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Summarized by type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment, and reversibility or outcome.

Time frame
Up to 18 weeks
2

Incidence of adverse events

Assessed using CTCAE v.5.0. Summarized by grade and attribution. Post-surgical complications will be assessed by Clavien-Dindo classification.

Time frame
From day 1 of protocol therapy until week 18

Secondary outcomes

1

Percentage of evaluable patients who have achieved complete response (CR), partial response (PR), or stable disease (SD)

Assessed by Response Evaluation Criteria in Solid Tumors criteria version 1.1 via computed tomography (CT) scan. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach by Clopper and Pearson.

Time frame
At baseline, following the second cycle (week 10), and 6 weeks after completing treatment (at 18 weeks/off-study)
2

Percentage of evaluable patients who have achieved CR, PR, or SD

Assessed by Peritoneal Carcinomatosis Index. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach by Clopper and Pearson.

Time frame
At the time of laparoscopy (or CT imaging if laparoscopy is not planned during surgery)
3

Percentage of evaluable patients who have achieved a decrease in Peritoneal Regression Grading Score over successive biopsies

The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach by Clopper and Pearson.

Time frame
Up to 18 weeks
4

Progression-free survival

Described using the Kaplan-Meier method.

Time frame
Time from first pressurized intraperitoneal aerosolized chemotherapy (PIPAC) procedure, assessed up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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