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A Phase II Trial of Gemcitabine Plus UFTE Combination Chemotherapy as Salvage Treatment in Oxaliplatin, Irinotecan and Fluoropyrimidine-Refractory Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic or Recurrent Colorectal Cancer, Refractory to Fluoropyrimidine, Oxaliplatin and Irinotecan, Salvage Chemotherapy

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Trial Information

A Phase II Trial of Gemcitabine Plus UFTE Combination Chemotherapy as Salvage Treatment in Oxaliplatin, Irinotecan and Fluoropyrimidine-Refractory Metastatic Colorectal Cancer


Inclusion Criteria:



- Age: ≥ 18 years old

- ECOG performance status: 0 to 2

- Pathologically proven adenocarcinoma of colorectum

- Patients who had received all cytotoxic drugs of 3 categories (fluoropyrimidine
[5-FU, capecitabine or S-1 etc.], oxaliplatin and irinotecan).

- Refractory MRCRC that progressed while receiving, or within 6 months after the
discontinuation of all of fluoropyrimidine, oxaliplatin and irinotecan. When retry of
fluoropyrimidine, oxaliplatin or irinotecan is not possible due to previous severe
toxicities despite progression-free interval ≥ 6 months, patients can be enrolled
into this study.

- Patients who were previously treated with cetuximab or to whom cetuximab cannot be
used (i.e. K-ras mutant or economical problems)

- At least one measurable lesion should exist (RECIST version 1.1)

Exclusion Criteria:

- Patients who had not previously received all of fluoropyrimidine, oxaliplatin and
irinotecan will be excluded.

- Patients who had received UFTE chemotherapy previously. However, if UFTE chemotherapy
was used as adjuvant chemotherapy and the disease-free interval was greater than 6
months, the patient can be included into this study.

- Patients receiving active or passive immunotherapy

- Patients with complete bowel obstruction or progressive symptoms of partial bowel
obstruction that interfere with adequate oral diet.

- Patients with large amount of ascites requiring frequent therapeutic paracentesis (>
once per week)

- Pregnant or breast-feeding women (a pregnancy test must be performed on all female
patients who are of child-bearing potential before entering the study)

- Women of child-bearing potential who are unwilling or unable to use an acceptable
method to avoid pregnancy for the entire study period. Sexually active fertile men
not using effective birth control during the study if their partners are women of
child-bearing potential

- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose
control may be jeopardized by complications of study therapy (i.e., uncontrolled
infection, uncontrolled epilepsy, cerebrovascular accidents within the past 6 months,
neurologic or psychological disease interfering with study treatment)

- Inadequate cardiovascular function:

- New York Heart Association class III or IV heart disease,

- Unstable angina or myocardial infarction within the past 6 months,

- Symptomatic coronary artery disease

- History of significant ventricular arrhythmia requiring medication with
antiarrhythmics or significant conduction system abnormality

- Symptomatic severe interstitial lung disease or pulmonary fibrosis

- Patients with impaired renal function: Creatinine clearance < 50mL/min (calculated by
Cockcroft and Gault formula)

- Patients with laboratory results as follows;

- Number of absolute neutrophil counts (ANC) < 1.5 x 10^9/L

- Number of thrombocytes < 100 x 10^9/L

- Total bilirubin > 1.5 x upper limit of normal

- ALAT, ASAT > 3 x upper limit of normal (in the cases with liver metastasis, >
ALAT, ASAT > 5 x upper limit of normal)

- Alkaline phosphatase > 3 x upper limit of normal (in the cases with liver or
bone metastasis, > 5 x upper limit of normal)

- Major surgery within 4 weeks of start of study treatment, without complete recovery

- Patients who were included to other clinical trials within the past 4 weeks.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

8-weeks progression free survival rate (PFS rate)

Outcome Description:

% of patients without tumor prgression at 8 weeks after the initiation of chemotherapy

Outcome Time Frame:

Response evaluation using computed tomography (CT) at 8 weeks after the initiation of chemotherapy

Safety Issue:

No

Principal Investigator

Jee Hyun Kim, M.D. & Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Professor, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

Authority:

South Korea: Institutional Review Board

Study ID:

CRC-SNU-2011-01

NCT ID:

NCT01409005

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Metastatic or Recurrent Colorectal Cancer
  • Refractory to Fluoropyrimidine, Oxaliplatin and Irinotecan
  • Salvage Chemotherapy
  • Colorectal Neoplasms

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