Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Richard T Penson, MD

The main purpose of this study is to determine the safety and tolerability of giving both paclitaxel and carboplatin in the abdominal cavity by looking at what effects (good and bad) this route of administration has on patients with ovarian cancer. Standard chemotherapy drugs are administered intravenously but a number of trials have shown that injecting drugs into the abdominal cavity, or intraperitoneally, have shown promising results.

Patients will have an intraperitoneal port placed at the time of their initial surgery or at a second procedure prior to cycle 2 of chemotherapy.

Patients will receive a total of 6 cycles of therapy as an outpatient. They will have 1 cycle of paclitaxel/carboplatin intravenously followed by 5 cycles of paclitaxel/carboplatin intraperitoneally. Chemotherapy treatment is given on days 1, 8, and 15 of each cycle. Each cycle is 21 days long.

To help reduce the chance of an allergic reaction, patients will also take decadron tablets orally before paclitaxel administration.

About 1 liter of standard salt solution will be injected through a catheter into the abdominal cavity with each treatment to help distribute the drugs throughout the abdominal cavity.

"Second-look" surgery (laparoscopy or laparotomy) will be performed 3-8 weeks after the last chemotherapy course (cycle 6) if the patient is in complete clinical remission. This surgery is done to see how effective the chemotherapy was.

Tests and procedures will be done throughout the treatment to see how the cancer is responding and to monitor for safety purposes. These tests and procedures include routine history and physical exam, neurological exam, and routine blood tests. As part of this study we will also be checking the amount of paclitaxel and carboplatin in the blood.

Participation in this study will last approximately 6 months as long as the treatment is well tolerated, there are no serious side effects and the disease has not progressed.

Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin

A Phase II Trial of Intraperitoneal Paclitaxel and Carboplatin Therapy in the Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Clinical Director Medical Gynecologic Oncology

Symptoms and General Pathology

Digestive System Diseases

Neoplasm Metastasis

Stomach Neoplasms

Peritoneal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Abdominal Neoplasms

Peritoneal Diseases

Stomach Cancer

Micronutrients

Leucovorin

Fluorouracil

Oxaliplatin

Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)

Intraperitoneal application of Paclitaxel Phase 1: Dose determination of Paclitaxel (Recommended Dose) Starting from 40mg/m² upto 100mg/m² maximum

Phase 2: Intraperitoneal Paclitaxel with recommended dose

Systemic mFOLFOX6: 5-FU(2400mg/m²), Oxaliplatin(100mg/m²), Leucovorin(100mg/m²)

mFOLFOX6 regimen

Hyung-Ho Kim, M.D., PhD.

Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. Intraperitoneal chemotherapy in combination with systemic chemotherapy is under many clinical trials mainly in Japan, and are showing promising results.

This is Korea's first clinical trial on Intraperitoneal Paclitaxel with Systemic mFOLFOX6 chemotherapy.

Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy

Dosage determination of Intraperitoneal Paclitaxel

1 year Overall survival with determined dose from Phase 1

Tumor response with RECIST criteria V.1.1 and Peritoneal Regression Grading Score(PRGS) system

Conversion surgery after stable disease or regression

Boryung Pharmaceutical Co., Ltd

B. Braun Korea Co., Ltd.

Seoul National University Bundang Hospital

Professor

Adenocarcinoma

Adenocarcinoma of the Appendix

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Dexamethasone

Dexamethasone acetate

BB 1101

Diphenhydramine

Promethazine

Famotidine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Antacids

Anti-Ulcer Agents

Histamine H2 Antagonists

Participants will be assigned to a study phase (Phase I or Phase II) based on when participants join this study. Up to 4 groups of at least 3 participants will be enrolled in Phase I of the study, and up to 15 participants will be enrolled in Phase II.

If you are enrolled in Phase I, the dose of paclitaxel you receive will depend on when the participants join this study. The first group of participants will receive the lowest dose level of paclitaxel. Each new group will receive a higher dose of paclitaxel than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of paclitaxel given intraperitoneally is found.

Participants who are enrolled in Phase II, participants will receive paclitaxel at the recommended dose that was found in Phase I.

Beth Helmink, MD

To find the recommended dose of the drug paclitaxel that can be given intraperitoneally (given directly into the abdominal cavity) to participants with metastatic appendiceal adenocarcinoma.

Primary (Phase I):

1. To assess the maximum tolerated dose (MTD) of paclitaxel via IP route given every 14 days in subjects with metastatic appendiceal adenocarcinoma

   Primary (Phase II):
2. To assess the pathologic and radiographic objective response rate of paclitaxel via IP route in participants with metastatic appendiceal adenocarcinoma

Secondary Objectives

1. To assess the progression-free and overall survival of metastatic appendiceal adenocarcinoma treated with IP paclitaxel. Although the clinical benefit of this drug has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the participants will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability
2. To assess the pharmacokinetics of IP PTX
3. To assess the change in PCI following IP PTX in patients with metastatic appendiceal adenocarcinoma
4. To assess rate of initially unresectable participants with metastatic appendiceal adenocarcinoma able to undergo CRS / HIPEC after IP PTX
5. To assess the rate of conversion from positive to negative cytology in peritoneal fluid following IP PTX in participants with metastatic appendiceal adenocarcinoma
6. To assess the prognostic value of circulating tumor DNA (ctDNA) in participants with metastatic appendiceal adenocarcinoma and the correlation of quantitative ctDNA measurement with radiographic and pathologic response
7. To generate PDX and PDO models of appendiceal adenocarcinoma and evaluate their ability to predict response of human tumors
8. To evaluate the effect of IP PTX on the transcriptomic state of appendiceal adenocarcinoma and the tumor microenvironment (TME) through comparison of pre- and post-treatment specimens
9. To assess the impact of GNAS, KRAS, TP53, and APC mutation on response to IP PTX therapy
10. To assess the impact of mucinous, signet ring cell, and goblet cell histology on response to IP PTX therapy

A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin	NCT00181701	Ovarian Carcino...	Paclitaxel Carboplatin	18 Years -	Massachusetts General Hospital
Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6	NCT03618758	Gastric Cancer ... Peritoneal Carc... Intraperitoneal... mFOLFOX6	Paclitaxel mFOLFOX6 regime...	20 Years - 79 Years	Seoul National University Bundang Hospital
Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin	NCT00181701	Ovarian Carcino...	Paclitaxel Carboplatin	18 Years -	Massachusetts General Hospital
Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin	NCT00181701	Ovarian Carcino...	Paclitaxel Carboplatin	18 Years -	Massachusetts General Hospital
Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6	NCT03618758	Gastric Cancer ... Peritoneal Carc... Intraperitoneal... mFOLFOX6	Paclitaxel mFOLFOX6 regime...	20 Years - 79 Years	Seoul National University Bundang Hospital
A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma	NCT06207305	Metastatic Appe... Intraperitoneal...	Dexamethasone Diphenhydramine Famotidine Paclitaxel	18 Years -	M.D. Anderson Cancer Center

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