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Safety and Efficacy Study of mFOLFOX6 + Panitumumab Combination Therapy and 5-FU/LV + Panitumumab Combination Therapy in Patients With Chemotherapy-naïve Unresectable Advanced Recurrent Colorectal Carcinoma

Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Carcinoma

Intervention: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab (Drug); oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
General Manager, Study Director, Affiliation: Takeda

Overall contact:
Takeda Study Registration Call Center, Phone: +1-800-778-2860 (USA & EU), Email: medicalinformation@tpna.com

Summary

The purpose of this study is to exploratorily examine efficacy and safety in the patients with chemotherapy-nave unresectable, advanced/recurrent colorectal carcinoma of KRAS wild-type who have been treated with 6 cycles (2 weeks/cycle) of first-line mFOLFOX6 + panitumumab combination therapy and then assigned to two groups i. e., a group receiving 5-FU/LV + panitumumab combination therapy and a group receiving mFOLFOX6 + panitumumab combination therapy.

Clinical Details

Official title: SAPPHIRE Study - A Phase II Randomized Study Comparing the Efficacy and Safety of mFOLFOX6 + Panitumumab Combination Therapy and 5-FU/LV + Panitumumab Combination Therapy in the Patients With Chemotherapy-nave Unresectable Advanced Recurrent Colorectal Carcinoma of KRAS Wild-type After 6 Cycles of Combination Therapy With mFOLFOX6 +

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-Free Survival rate (PFS rate) at 9 months after randomization

Secondary outcome:

Progression-Free Survival (PFS)

Overall survival (OS)

Response rate (RR)

Time to treatment failure (TTF)

Frequency of adverse events rate

Detailed description: This open label study will exploratorily examine efficacy and safety of 5-FU/LV + panitumumab combination therapy or mFOLFOX6 + panitumumab combination therapy in the patients with chemotherapy-naïve unresectable, advanced/recurrent colorectal carcinoma of KRAS wild-type who have been treated with 6 cycles [2 weeks/cycle (site visit)] of first-line mFOLFOX6 + panitumumab combination therapy The study will enroll approximately 100 patients. All patients will receive 6 cycles of Protocol Treatment [1]: mFOLFOX6 + panitumumab combination therapy [oxaliplatin (OXA): 85 mg/m2/day 1; levofolinate calcium (l-LV): 200 mg/m2/day 1; bolus 5-FU: 400 mg/m2/day 1; infusional 5-FU: 2400 mg/m2/day 1-3; panitumumab: 6 mg/kg] once every two weeks. Then they will be randomly assigned (by chance, like flipping a coin) to one of the treatment groups.

- Group A (50 Patients): mFOLFOX6 + panitumumab combination therapy, once every two weeks

[oxaliplatin (OXA): 85 mg/m2/day 1; levofolinate calcium (l-LV): 200 mg/m2/day 1; bolus 5-FU: 400 mg/m2/day 1; infusional 5-FU: 2400 mg/m2/day 1-3; panitumumab: 6 mg/kg]

- Group B (50 patients): 5-FU/LV + panitumumab combination therapy, once every two weeks

[levofolinate calcium (l-LV): 200 mg/m2/day 1; bolus 5-FU: 400 mg/m2/day 1; infusional 5-FU: 2400 mg/m2/day 1-3; panitumumab: 6 mg/kg] This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 12 months.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria for enrollment: 1. Patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer) 2. Patients with measurable lesion(s) according to the RECIST ver. 1. 1 3. Patients who have not received chemotherapy for colorectal cancer. Patients who experience relapse more than 6 months after the final dose of perioperative adjuvant chemotherapy with fluoropyrimidine agents may be enrolled. 4. Aged ≥ 20 years at the time of informed consent 5. Patients classified as KRAS wild-type. However, the criteria will be changed to all patients who are verified to be of KRAS and NRAS wild-type when the KRAS and NRAS tests come to be covered by National Health Insurance, and the tests become feasible at medical institutions. 6. Patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment 1) Neutrophil count ≥ 1. 5 × 103/μL 2) White blood cell count ≥ 3. 0 × 103/μL 3) Platelet count ≥ 10. 0 × 104/μL 4) Hemoglobin ≥ 9. 0 g/dL 5) Total bilirubin ≤ 2. 0 mg/dL 6) AST ≤ 100 U/L (≤ 200 U/L if liver metastases are present) 7) ALT ≤ 100 U/L (≤ 200 U/L if liver metastases are present) 8) Serum creatinine ≤ 1. 5 mg/dL 7. Patients who are assessed at Eastern Cooperative Oncology Group (ECOG) performance status (P. S.) of 0 or 1 8. Life expectancy of ≥ 6 months after enrollment 9. Patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment Inclusion criteria for randomization: 1. Patients who have received 6 cycles of mFOLFOX6 + panitumumab combination therapy 2. Patients who are assessed at ECOG P. S. of 0-1 in the 6th cycle. 3. Patients for whom PD or not evaluable has been denied on the RECIST based on imaging tests conducted after the day of administration in the 6th cycle within 14 days (2 weeks). Exclusion Criteria for enrollment: 1. Radiotherapy received for a measurable lesion 2. Radiotherapy received within 28 days (4 weeks) prior to enrollment for a lesion other than measurable lesions 3. Known brain metastasis or strongly suspected of brain metastasis 4. Synchronous cancers or metachronous cancers with a disease-free period of ≤ 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.). 5. Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.) 6. Patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy 7. Active hemorrhage requiring blood transfusion 8. Disease requiring systemic steroids for treatment (excluding topical steroids) 9. Intestinal resection and colostomy within 2 weeks prior to enrollment 10. History or obvious and extensive CT findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.) 11. Serious drug hypersensitivity 12. Local or systemic active infection requiring treatment, or fever indicating infection 13. Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhea (incapacitating symptoms despite adequate treatment) 14. Active hepatitis B and/or active hepatitis C 15. Known human immunodeficiency virus infection 16. Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study Exclusion criteria for randomization: 1. Patients in whom interstitial pneumonia has been newly diagnosed during the period from registration to randomization 2. Patients who have received radiotherapy during the period from registration to randomization 3. Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study

Locations and Contacts

Takeda Study Registration Call Center, Phone: +1-800-778-2860 (USA & EU), Email: medicalinformation@tpna.com

Akita, Japan; Recruiting
Additional Information

Starting date: October 2014
Last updated: January 13, 2015

Page last updated: August 23, 2015

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