Phase I open label trial of intraperitoneal paclitaxel in combination with intravenous cisplatin and oral capecitabine in patients with advanced gastric cancer and peritoneal metastases
Phase I open label trial of the safety and tolerability of intraperitoneal paclitaxel in combination with intravenous cisplatin and oral capecitabine in patients with advanced gastric cancer and peritoneal metastases
A/Prof Chris Karapetis
18 participants
Dec 4, 2014
Interventional
Conditions
Summary
This is a Phase I trial to determine safety and tolerability of paclitaxel in combination with cisplatin and capecitabine in patients with advanced gastric cancer and peritoneal metastases. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with gastric cancer and peritoneal metastases, and have not had previous chemotherapy for metastatic gastric cancer. Study details All participants will be given the combined treatment of paclitaxel, given through an intraperitoneal catheter (a thin tube surgically inserted through the stomach cavity), cisplatin, given intravenously (through a tube inserted into the vein), and capecitabine, given orally. Different doses will be tested to determine the maximum tolerated dose for paclitaxel. Participants will be follow-up for up to 6 cycles, or 18 weeks, during treatment and then for a further two years post treatment in order to determine safety and tolerability of paclitaxel, response rate, survival and effect of treatment on quality of life.
Eligibility
Inclusion Criteria15
- Age greater than or equal to 18 years
- A diagnosis of Gastric cancer proven by histopathology and either:
- Biopsy proven peritoneal metastases OR
- Cytology consistent with malignant ascites: in which case patient must have greater than or equal to 1 area of metastasis apart from the ascites.
- Subject must not have received previous chemotherapy for metastatic gastric cancer
- Previous adjuvant chemotherapy for gastric cancer is allowed
- Adequate bone marrow function (platelets > 100 x 109/L, ANC > 1.5 x 109/L, P)
- Adequate liver function (Serum bilirubin less than or equal to 1.5 ULN and ALT and ALP less than or equal to 3 ULN,)
- Adequate renal function (Serum creatinine less than or equal to 1.5 UNL or creatinine clearance (CRCL) greater than or equal to 50ml/min (using Cockcroft-Gault Equation) )
- negative pregnancy test if of potential child bearing age
- Eastern Cooperative Oncology Group Performance Score (ECOG PS) 0, 1 or 2
- Staging CT scan of chest/abdomen/pelvis within 30 days of registration
- Study treatment both planned and able to start within 30 days of registration
- Willing and able to comply with all study requirements, including treatment (able to swallow tablets), and required assessments
- Signed, written informed consent
Exclusion Criteria17
- Contraindications to investigational chemotherapy regimen including allergies to any of the chemotherapy medications
- Specific comorbidities or conditions
- Other, for example those compromising the ability to assess key outcomes
- Life expectancy of less than 3 months.
- History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated cervical carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.
- Significant intercurrent illness that will interfere with the chemotherapy during the trial such as:
- a. Known Human Immunodeficiency Virus (HIV) infection
- b. Active infection
- c. Myocardial infarction within the previous 6 months or significant cardiac disease resulting in an inability to tolerate the intravenous fluid load as required for administration of cisplatin
- d. Severe lung disease which in the investigators opinion would limit the patient’s ability to tolerate large volumes of intra-abdominal fluids.
- Peripheral neuropathy of any grade (based on NCI CTC version 4.0)
- Clinically significant sensori-neural hearing impairment or tinnitus which may be exacerbated by cisplatin (Audiometric abnormalities without corresponding clinical deafness will not be grounds for exclusion).
- Previous abdominal or pelvic radiation treatment.
- Significant intra-abdominal adhesions as determined by the surgeon at time of staging laparoscopy.
- Active intra-abdominal sepsis
- Medical or psychiatric condition that compromises the ability of patients to give informed consent.
- Pregnancy, lactation, or inadequate contraception. Women must be postmenopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a barrier method of contraception during treatment and for the subsequent three months after treatment.
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Interventions
Each Cycle will be 21 days and includes the following combination: Capecitabine (oral) 1000 mg/m2 twice a day, day 1 to 14 every 21 days Cisplatin at 80 mg/m2 day (IV), day 1 every 21 days Intraperitoneal paclitaxel will be given by chemotherapy trained nursing staff on day 1 and day 8 of a 21 day cycle. The dose of paclitaxel will vary depending on the cohort Cohort 1 10mg/m2 Cohort 2 20mg/m2 Cohort 3 30mg/m2 Patients will receive 6 cycles of chemotherapy unless unacceptable toxicity or progression of disease occurs.
Locations(1)
View Full Details on ANZCTR
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ACTRN12614001063606