Diseases of Oesophagus Stomach and DuodenumPhase 1NCT03330028
Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
A Phase 1 study testing Dexamethasone, Diphenhydramine and Famotidine in people with Diseases of Oesophagus Stomach and Duodenum, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of paclitaxel that can be given as hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with gastric or gastroesophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diseases of Oesophagus Stomach and Duodenum
- What is being tested?
- Dexamethasone, Diphenhydramine and Famotidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2017to 18 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and above. There will be no upper age restriction.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
- Adequate renal, and bone marrow function: a. Leukocytes >= 3,000/uL b. Absolute neutrophil count >= 1,500/uL c. Platelets >= 60,000/Ul d. Serum creatinine <= 1.5 mg/dL
- Distant Metastatic Disease of peritoneum: a. Positive peritoneal cytology b. Carcinomatosis on diagnostic laparoscopy or laparotomy.
- Completion of preoperative systemic chemotherapy.
Who cannot join
- Infections such as pneumonia or wound infections that would preclude protocol therapy.
- Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
- Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
- Subjects deemed unable to comply with study and/or follow-up procedures.
- Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
The goal of this clinical research study is to find the highest tolerable dose of paclitaxel that can be given as hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with gastric or gastroesophageal cancer. HIPEC is a system in which heated chemotherapy is delivered directly inside the abdomen during surgery. In this study, paclitaxel is being combined with mitomycin and cisplatin to see if this study drug combination can help to control the disease.
This is an investigational study. Mitomycin, cisplatin, and paclitaxel are FDA-approved and commercially available for the treatment of gastric and gastroesophageal cancer. It is investigational to give these drugs by HIPEC.
Read more
The study doctor can describe how the study drugs and HIPEC are designed to work.
Up to 48 participants will be enrolled in this study. All will take part at MD Anderson.
Read the detailed description
Study Groups:
If participant is found to be eligible to take part in this study, participant will be assigned to a dose level of paclitaxel based on when participant joins this study. Up to 8 dose levels of paclitaxel will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of paclitaxel is found.
All participants will receive the same dose level of mitomycin and cisplatin.
HIPEC Treatment and Study Visits:
On the day of HIPEC treatment, participant will receive heated mitomycin, cisplatin, and paclitaxel as a liquid that is injected through 3 to 4 small incisions in participant's abdomen over about 1 hour. Heated mitomycin, cisplatin, and paclitaxel will be delivered through plastic tubing that is connected to a pump into the abdominal cavity. The pump pushes the heated drugs into the abdominal cavity and then pulls it out and recirculates the drugs. The skin of the abdominal cavity is temporarily closed during this procedure. A pump will be used to pump the heated drugs in and out of the abdominal cavity over 60 minutes while the surgeon gently presses on the abdominal wall so the drugs can reach all areas in the abdominal cavity. After 60 minutes, the drugs are removed and the abdominal cavity will be washed. The remaining fluid will be removed before the surgeon closes the abdominal cavity with stitches.
Additionally, participant will be given standard drugs to help decrease the risk of side effects. Participant may ask the study staff for information about how the drugs are given and their risks.
Participant will remain in the hospital for 3-7 days after treatment.
While participant is in the hospital after surgery, blood (about 2-3 tablespoons) may be drawn for routine tests at any time that the study doctor thinks it is needed.
One (1) time between 2-6 weeks after HIPEC Treatment:
- Participant will have a physical exam.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
Follow-Up Visits:
Participant will have routine clinic visits or participant will be called every 6 months after the HIPEC procedure. Participant will be asked about any other cancer treatments participant may be receiving. If participant is called, these calls should last about 5-10 minutes. If participant stopped the study early, the study doctor may ask participant to return to the clinic for extra CT scans, PET scan, or MRIs during the follow-up period.
Participant will have a CT scan, PET scan, or MRI of participant's chest, abdomen, and pelvis every 6 months for 5 years after surgery to check the status of the disease.
Length of Study Participation:
Participant will be on study for about 5 years after participant's last procedure (HIPEC or surgery). Participant will be taken off study early if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.
Participation on the study will be over after the follow-up visits.
- Being tested
- Dexamethasone, Diphenhydramine, Famotidine, Mitomycin C, Cisplatin
- Keywords
- Diseases of oesophagus stomach and duodenum, Gastric cancer, Gastroesophageal cancer, Adenocarcinoma of the stomach or gastroesophageal junction, Hyperthermic intraperitoneal chemotherapy, HIPEC, Paclitaxel, Taxol, Dexamethasone, Decadron, Diphenhydramine, Benadryl, Cisplatin, Platinol-AQ, Platinol, CDDP, Mitomycin-C, Mitomycin, Famotidine, Pepcid
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
10 mg by vein approximately 60 minutes before Paclitaxel.
DiphenhydramineDrug
Also called Benadryl
50 mg by vein approximately 60 minutes before Paclitaxel.
FamotidineDrug
Also called Pepcid
20 mg by vein approximately 60 minutes before Paclitaxel.
Mitomycin CDrug
Also called Mitomycin
Mitomycin C 30 mg in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.
CisplatinDrug
Also called Platinol-AQ, Platinol, CDDP
Cisplatin 200 mg in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.
PaclitaxelDrug
Also called Taxol
Starting dose of Paclitaxel is 20 mg/m2 in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.
Dose-escalation scheme of Paclitaxel is in increments of 5 mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) | Experimental | Participants receive heated Mitomycin, Cisplatin, and Paclitaxel as a liquid that is injected through 3 to 4 small incisions into the abdomen over about 1 hour. Receives: Drug: Dexamethasone; Drug: Diphenhydramine; Drug: Famotidine; Drug: Mitomycin C; Drug: Cisplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Paclitaxel via Intraperitoneal Route Combined with Fixed Doses of Mitomycin and Cisplatin during Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
MTD selected based on isotonic regression as specified per methods by Liu and Yuan.
Measured: 3 to 7 days after Hyperthermic Intraperitoneal Chemotherapy (HIPEC) infusion
Dose Limiting Toxicity (DLT) of Paclitaxel via Intraperitoneal Route Combined with Fixed Doses of Mitomycin and Cisplatin during Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Dose limiting toxicity (DLT) graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) by organ system. DLT defined as any grade III/IV non-hematologic or neutropenia-associated (infection or fever treated in the hospital) toxicity attributable to this therapy.
Measured: Within 21 days after Hyperthermic Intraperitoneal Chemotherapy (HIPEC) infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start27 Oct 2017
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diseases of Oesophagus Stomach and DuodenumStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian D. Badgwell, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330028
- Sponsor's protocol ID
- 2017-0232
- Other IDs
- NCI-2018-01035
- Status last verified
- Apr 2023
- First submitted
- 31 Oct 2017
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
- ClinicalTrials.gov ID
- NCT03330028
- Acronym / sponsor ID
- 2017-0232
- Keywords
- Diseases of oesophagus stomach and duodenum, Gastric cancer, Gastroesophageal cancer, Adenocarcinoma of the stomach or gastroesophageal junction, Hyperthermic intraperitoneal chemotherapy, HIPEC, Paclitaxel, Taxol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to find the highest tolerable dose of paclitaxel that can be given as hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with gastric or gastroesophageal cancer. HIPEC is a system in which heated chemotherapy is delivered directly inside the abdomen during surgery. In this study, paclitaxel is being combined with mitomycin and cisplatin to see if this study drug combination can help to control the disease.
This is an investigational study. Mitomycin, cisplatin, and paclitaxel are FDA-approved and commercially available for the treatment of gastric and gastroesophageal cancer. It is investigational to give these drugs by HIPEC.
The study doctor can describe how the study drugs and HIPEC are designed to work.
Up to 48 participants will be enrolled in this study. All will take part at MD Anderson.
Detailed description
Study Groups:
If participant is found to be eligible to take part in this study, participant will be assigned to a dose level of paclitaxel based on when participant joins this study. Up to 8 dose levels of paclitaxel will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of paclitaxel is found.
All participants will receive the same dose level of mitomycin and cisplatin.
HIPEC Treatment and Study Visits:
On the day of HIPEC treatment, participant will receive heated mitomycin, cisplatin, and paclitaxel as a liquid that is injected through 3 to 4 small incisions in participant's abdomen over about 1 hour. Heated mitomycin, cisplatin, and paclitaxel will be delivered through plastic tubing that is connected to a pump into the abdominal cavity. The pump pushes the heated drugs into the abdominal cavity and then pulls it out and recirculates the drugs. The skin of the abdominal cavity is temporarily closed during this procedure. A pump will be used to pump the heated drugs in and out of the abdominal cavity over 60 minutes while the surgeon gently presses on the abdominal wall so the drugs can reach all areas in the abdominal cavity. After 60 minutes, the drugs are removed and the abdominal cavity will be washed. The remaining fluid will be removed before the surgeon closes the abdominal cavity with stitches.
Additionally, participant will be given standard drugs to help decrease the risk of side effects. Participant may ask the study staff for information about how the drugs are given and their risks.
Participant will remain in the hospital for 3-7 days after treatment.
While participant is in the hospital after surgery, blood (about 2-3 tablespoons) may be drawn for routine tests at any time that the study doctor thinks it is needed.
One (1) time between 2-6 weeks after HIPEC Treatment:
- Participant will have a physical exam.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
Follow-Up Visits:
Participant will have routine clinic visits or participant will be called every 6 months after the HIPEC procedure. Participant will be asked about any other cancer treatments participant may be receiving. If participant is called, these calls should last about 5-10 minutes. If participant stopped the study early, the study doctor may ask participant to return to the clinic for extra CT scans, PET scan, or MRIs during the follow-up period.
Participant will have a CT scan, PET scan, or MRI of participant's chest, abdomen, and pelvis every 6 months for 5 years after surgery to check the status of the disease.
Length of Study Participation:
Participant will be on study for about 5 years after participant's last procedure (HIPEC or surgery). Participant will be taken off study early if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.
Participation on the study will be over after the follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) | Experimental | Drug: Dexamethasone, Drug: Diphenhydramine, Drug: Famotidine, Drug: Mitomycin C, Drug: Cisplatin, Drug: PaclitaxelParticipants receive heated Mitomycin, Cisplatin, and Paclitaxel as a liquid that is injected through 3 to 4 small incisions into the abdomen over about 1 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years and above. There will be no upper age restriction.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
- Adequate renal, and bone marrow function: a. Leukocytes >= 3,000/uL b. Absolute neutrophil count >= 1,500/uL c. Platelets >= 60,000/Ul d. Serum creatinine <= 1.5 mg/dL
- Distant Metastatic Disease of peritoneum: a. Positive peritoneal cytology b. Carcinomatosis on diagnostic laparoscopy or laparotomy.
Key exclusion criteria (5 listed)
- Infections such as pneumonia or wound infections that would preclude protocol therapy.
- Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
- Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
- Subjects deemed unable to comply with study and/or follow-up procedures.
- Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Decadron10 mg by vein approximately 60 minutes before Paclitaxel. | Drug | Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) |
| DiphenhydramineAlso: Benadryl50 mg by vein approximately 60 minutes before Paclitaxel. | Drug | Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) |
| FamotidineAlso: Pepcid20 mg by vein approximately 60 minutes before Paclitaxel. | Drug | Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) |
| Mitomycin CAlso: MitomycinMitomycin C 30 mg in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen. | Drug | Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) |
| CisplatinAlso: Platinol-AQ, Platinol, CDDPCisplatin 200 mg in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen. | Drug | Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) |
| PaclitaxelAlso: TaxolStarting dose of Paclitaxel is 20 mg/m2 in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen. Dose-escalation scheme of Paclitaxel is in increments of 5 mg/m2. | Drug | Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) |
Primary outcome
Maximum Tolerated Dose (MTD) of Paclitaxel via Intraperitoneal Route Combined with Fixed Doses of Mitomycin and Cisplatin during Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Time frame: 3 to 7 days after Hyperthermic Intraperitoneal Chemotherapy (HIPEC) infusion
MTD selected based on isotonic regression as specified per methods by Liu and Yuan.
Dose Limiting Toxicity (DLT) of Paclitaxel via Intraperitoneal Route Combined with Fixed Doses of Mitomycin and Cisplatin during Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Time frame: Within 21 days after Hyperthermic Intraperitoneal Chemotherapy (HIPEC) infusion
Dose limiting toxicity (DLT) graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) by organ system. DLT defined as any grade III/IV non-hematologic or neutropenia-associated (infection or fever treated in the hospital) toxicity attributable to this therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian D. Badgwell, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone, Diphenhydramine and Famotidine in people with Diseases of Oesophagus Stomach and Duodenum, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Paclitaxel via Intraperitoneal Route Combined with Fixed Doses of Mitomycin and Cisplatin during Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (time frame: 3 to 7 days after Hyperthermic Intraperitoneal Chemotherapy (HIPEC) infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.