Patients expected to receive a 500 mg/m2 of Leucovorin by iv \& 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours \& 11 hours post 5-FU iv bolus. This treatment cycle will continue weekly for 6 weeks. The TK112690 dose will be 45 mg/kg.
Patients expected to receive a 500 mg/m2 of Leucovorin by iv \& 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours \& 11 hours post 5-FU iv bolus. This treatment cycle will continue weekly for 6 weeks. The TK112690 dose will be 45 mg/kg. * 24 patients will be randomized equally into 2 different groups: TK-90 treated or TK-90 placebo treated. * Screening must be completed within 2 weeks. * The treatment period for the study is 6 weeks. * Study follow-up will be scheduled post two weeks of completion of last dose of Chemotherapy \& TK-90 * Blinding: The study will be partially blinded. The patient and investigator as well as site personnel will be blinded as to whether TK-90 or TK-90 placebo is administered. The CRO, sponsor, and site pharmacist will know whether the patient was administered active drug or TK-90 placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
24
Jawaharlal Nehru Cancer Hospital and Research Centre
Bhopal, Madhya Pradesh, India
Om Sai Onco Surgery Multispecialty Hospital Center
Kolhāpur, Maharashtra, India
B. J. Medical College and Sassoon General Hospital
Pune, Maharashtra, India
MTES Sanjeevan Hospital
Pune, Maharashtra, India
Mucositis
SOM (Severe Oral Mucositis) - Comparison of incidences of Grade 3 or 4 mucositis (WHO scale) in the treatment and placebo groups. Duration of SOM. Days patients suffer Grades 3 and 4 oral mucositis measured by WHO scale from the start of treatment. number of days from the first occurrence of WHO Grade 3 or 4 OM through the first occurrence of non-severe (≤ Grade 2) without a subsequent instance of ≥ Grade 3 OM. Subjects with complete study follow-up for severe OM who do not develop severe OM (grade 0-2) will be considered to have durations of 0 days
Time frame: 8 Weeks
Secondary efficacy/outcome mucositis
A) In addition to the WHO scale, mucositis status in the patients will also be evaluated using two different published and validated mucositis scales: NCI/CTCAE/mucositis, and PROMS. B) Comparison of WHO scale values of treated patients at each point of evaluation.
Time frame: 8 Weeks
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Saveetha Medical college Chennai
Chennai, Tamil Nadu, India