Status and phase
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About
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.
Full description
Primary (Phase I):
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):
To assess the pathologic and radiographic objective response rate of paclitaxel via IP route in participants with metastatic appendiceal adenocarcinoma
Secondary Objectives
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age 18 years and above. There will be no upper age restriction
ECOG performance status ≤ 2
Participants must have histologically confirmed diagnosis of unresectable locally metastatic appendiceal adenocarcinoma
Metastatic disease in the peritoneal cavity and not a candidate for cytoreductive surgery
Participants must have adequate organ and marrow function as defined below:
leukocytes ≥3000/mcL absolute neutrophil count ≥1,500/mcL platelets ≥75,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) creatinine ≤ 1.5X institutional ULN
For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Participants with metastases outside the peritoneal cavity are not eligible for enrollment
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
The effects of PTX on the developing human fetus are unknown. For this reason, and because Taxane agents as well as other therapeutic agents used in this trial are known to be teratogenic, 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 and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of paclitaxel administration.
Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
39 participants in 1 patient group
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Central trial contact
Beth Helmink, MD
Data sourced from clinicaltrials.gov
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