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Peritoneal CarcinomatosisPhase 1NCT04583488

Intraperitoneal Docetaxel in Combination With mFOLFOX6 for Gastric Cancer Patients With Peritoneal Carcinomatosis

A Phase 1 study testing Intraperitoneal docetaxel in people with Peritoneal Carcinomatosis, run by Johns Hopkins University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a single-center, open-label, non-randomized, uncontrolled Phase 1 study of intraperitoneal docetaxel in combination with systemic mFOLFOX6 for patients who have gastric cancer with gross peritoneal carcinomatosis (GC-PC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peritoneal Carcinomatosis
What is being tested?
Intraperitoneal docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
1 Nov 2020to 6 Aug 2024
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

  • Have histologically-confirmed GC-PC by diagnostic laparoscopy who have not undergone chemotherapy for metastatic/recurrent disease.
  • Be willing and able to provide written informed consent/assent for the trial.
  • Be ≥ 18 years of age on day of signing informed consent.
  • Not have distant metastases as ruled out by an initial imaging (e.g. CT Chest/Abdomen/Pelvis with contrast), positron emission tomography (PET scan). Any metastasis in distant organs other than the peritoneum will exclude the patient from this study.
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale at study entry.
  • Demonstrate adequate organ function. All screening labs should be performed within 7 days prior to protocol therapy.
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  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
  • Willingness to undergo intraperitoneal port placement

Who cannot join

  • Has gastric cancer involving the distal esophagus above the gastroesophageal (GE) junction (Siewart type 1, proximally), or second portion of the duodenum (distally).
  • Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
  • Has a tumor positive for human epidermal growth factor receptor 2 (HER2) staining.
  • Has had prior surgery with dense intra-abdominal adhesions
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
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  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks (6 weeks for nitrosureas or mitomycin C) prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has an active infection requiring antibiotic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C virus (e.g., Hepatitis C virus RNA [qualitative] is detected).
  • Patients receiving any medications or substances that are inhibitors or inducers of Cytochrome P450 3A4 (CYP 3A4) are ineligible. Investigator can change to a similar agent that is a non-CYP3A4 inhibitor/inducer with a washout period of 1 week.
  • Patients with known hypersensitivity to any of the components of docetaxel or mFOLFOX6.
  • Patients who received pelvic or abdominal radiotherapy.
  • Peripheral neuropathy ≥ Grade 2.
  • History of allogeneic transplant.
  • Any known cardiac abnormalities, in accordance with mFOLFOX6 guidelines.
  • Any other condition that would render the patient to be unfit for the trial as deemed by the PI or clinical team.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: A Phase I Study of Intraperitoneal Docetaxel in Combination With 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6) for Gastric Cancer Patients With Peritoneal Carcinomatosis

This is a single-center, open-label, non-randomized, uncontrolled Phase 1 study of intraperitoneal docetaxel in combination with systemic mFOLFOX6 for patients who have gastric cancer with gross peritoneal carcinomatosis (GC-PC).

Read the detailed description

Gastric cancer (GC) is one of the leading causes of cancer-related deaths in the United States and has a five-year survival of 40% after surgical resection. Metastatic gastric cancer has an even poorer prognosis and most patients die within the first year of diagnosis. Most patients are diagnosed in advanced stages of the disease due to non-specific or lack of symptomatology and treatment options are then limited to systemic chemotherapy. The peritoneum is the most frequent site of metastasis as well as cancer recurrence. Peritoneal Carcinomatosis (PC) results in adverse clinical sequelae and is ultimately responsible for 60% of all gastric cancer-related deaths. While visceral metastases originating from primary gastric cancer are relatively chemosensitive, peritoneal carcinomatosis is particularly challenging to treat because of inadequate drug delivery from systemic circulation. The primary purpose of this trial is to determine the safety of administering intraperitoneal docetaxel in conjunction with the standard of care treatment regimen of intravenous mFOLFOX6 (5-Fluorouracil, leucovorin, and oxaliplatin) in patients with primary gastric cancer with gross peritoneal carcinomatosis.

Being tested
Intraperitoneal docetaxel
Keywords
gastric cancer, Peritoneal Surface Malignancies
Medical subject headings
Peritoneal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraperitoneal docetaxelDrug

    Also called Taxotere

    Up to 3 dose levels of intraperitoneal docetaxel will be studied (25mg/m2, 35 mg/m2, 45 mg/m2).

Study groups in NCT04583488
Study groupRoleWhat they receive
Intraperitoneal docetaxelExperimentalParticipants will receive intraperitoneal docetaxel combined with the standard of care. A standard 3 + 3 dose escalation design will be used according to the dose escalation plan.
Receives: Drug: Intraperitoneal docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    To determine the Maximum Tolerated Dose (MTD) of intraperitoneal docetaxel in conjunction with the standard of care treatment regimen of intravenous mFOLFOX6 in patients with primary gastric cancer with gross peritoneal carcinomatosis

    Measured: 20 weeks

Secondary outcomes (1)

  1. Progression-Free Survival

    Progression-free survival rate at 20 weeks, which is defined as the percentage of patients alive and free of disease progression at 20 weeks.

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2020
  2. Study start1 Nov 2020
  3. Primary completion6 Aug 2024
  4. Study completion6 Aug 2024

Why it stopped: PI left institution

Resources

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
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04583488
Sponsor's protocol ID
IRB00162730
Status last verified
Aug 2024
First submitted
5 Oct 2020
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intraperitoneal docetaxel in people with Peritoneal Carcinomatosis, run by Johns Hopkins University 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 10 inclusion and 22 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: stopped early, as of the sponsor's last update on 9 Aug 2024. 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 was stopped early (reason given: PI left institution). Results are not available in the source record.

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) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04583488.

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 9 Aug 2024.

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