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Trial record 6 of 4078 for:    colon cancer AND Intestinal Neoplasms

A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC

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ClinicalTrials.gov Identifier: NCT03303495
Recruitment Status : Recruiting
First Posted : October 6, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ruihua Xu, Sun Yat-sen University

Brief Summary:
The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Biological: Bevacizumab Drug: CPT-11 Drug: 5-FU Bolus Drug: 5-FU Infusion Drug: l-LV (dl-LV) Phase 3

Detailed Description:
Primary endpoint: Overall survival (OS), Secondary endpoints: Progression-free survival (PFS), Time to treatment failure (TTF), Overall response rate (ORR),Disease Control Rate (DCR), Safety.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multinational, Randomized, Phase III Study of FOLFIRI With/Without Bevacizumab Versus Irinotecan With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer
Actual Study Start Date : November 14, 2011
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FOLFIRI +/- Bevacizumab
Bevacizumab 5 mg/kg IV 90-30 min Day 1; CPT-11 180 mg/m2 IV 90 min Day 1; l-LV (dl-LV) 200 mg/m2 (400 mg/m2) IV 120 min Day 1; 5-FU - bolus 400 mg/m2 IV bolus Day 1; 5-FU - infusional 2400 mg/m2 IV continuous (46 hours) Day 1 - 3
Biological: Bevacizumab
5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.
Other Name: Avastin

Drug: CPT-11
180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle
Other Name: Irinotecan

Drug: 5-FU Bolus
400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
Other Name: fluorouracil

Drug: 5-FU Infusion
2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
Other Name: fluorouracil

Drug: l-LV (dl-LV)
200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Other Name: Leucovorin

Experimental: CPT-11 +/- Bevacizumab
Bevacizumab 5 mg/kg IV 90-30 min Day 1; CPT-11 180 mg/m2 IV 90 min Day 1
Biological: Bevacizumab
5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.
Other Name: Avastin

Drug: CPT-11
180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle
Other Name: Irinotecan




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Assessed until 1.5 years after the last patient enrolment ]
    Time from the date of enrollment to death from any cause


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Assessed until 1.5 years after the last patient enrolment ]
    Time from the date of enrollment to the earlier of the date of confirmed progression or death from any cause.

  2. Time to treatment failure (TTF) [ Time Frame: Assessed until 1.5 years after the last patient enrolment ]
    Time from the date of enrollment to the earlier of the date of confirmed progression, death from any cause, or discontinuation of protocol treatment.

  3. Overall Response Rate (ORR) [ Time Frame: Assessed at 6, 12 week and thereafter every 8 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks ]
    Proportion of eligible patients with measurable lesions with a best overall response of CR or PR assessed by the attending physician.

  4. Disease Control Rate (DCR) [ Time Frame: Assessed at 6, 12 week and thereafter every 8 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks ]
    Proportion of best overall response of CR, PR, or SD assessed by the attending physician.

  5. Incidence of Adverse Events (Adverse Reactions) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks ]
    The incidence of worst-grade adverse events (toxicities) on study as graded by NCI-CTCAE v 4.0 will be determined by treatment arm in all treated patients for the following events.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.
  2. Age ≥18 years at the time of informed consent
  3. ECOG performance status (PS) of 0-2
  4. Written informed consent prior to study-specific screening procedures
  5. Life expectancy of at least 90 days
  6. Withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy.
  7. Adequate organ function according to following laboratory values obtained within 14 days before enrolment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test) Neutrophil count: ≥1500/mm3 Platelet count: ≥10.0 x 104/mm3 Hemoglobin: ≥9.0 g/dL Total bilirubin: ≤1.5 mg/dL AST, ALT: ≤100 IU/L (≤200 IU/I if liver metastases present) Serum creatinine: ≤1.5 mg/dL

Exclusion Criteria:

  1. History of other malignancy with a disease-free interval <5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)
  2. With massive pleural effusion or ascites requiring intervention
  3. Radiological evidence of brain tumor or brain metastases
  4. Active infection including hepatitis
  5. Any of the following complication:

    i) Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus) ii) Symptomatic heart disease (including unstable angina, myocardial infarction, and heart failure) iii) Interstitial pneumonia or pulmonary fibrosis iv) Uncontrolled diabetes mellitus v) Uncontrolled diarrhea (that interferes with daily activities despite adequate therapy)

  6. Any of the following medical history:

    Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime episodes i) Serious hypersensitivity to any of the study drugs ii) History of adverse reaction to fluoropyrimidines suggesting dihydropyrimidine dehydrogenase (DPD) deficiency

  7. Previous treatment with irinotecan hydrochloride
  8. Current treatment with atazanavir sulfate
  9. Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment
  10. Pregnant or lactating females, and males and females unwilling to use contraception
  11. Requires continuous treatment with systemic steroids
  12. Psychiatric disability that would preclude study compliance
  13. Otherwise determined by the investigator to be unsuitable for participation in the study
  14. Concurrent gastrointestinal perforation or history of gastrointestinal perforation with 1 year before enrollment
  15. History of pulmonary hemorrhage/hemoptysis ≥ Grade 2 (defined as bright red blood of at least 2.5mL) within 1 month prior to enrollment.
  16. History of laparotomy, thoracotomy, or intestinal resection within 28 days before enrollment
  17. Unhealed wound (except suture wounds from implantation of a central venous port), gastrointestinal ulcer, or traumatic fracture
  18. Current or recent (within 1 year) thromboembolism or cerebrovascular disease
  19. Currently receiving or requires anticoagulation therapy (> 325 mg/day of aspirin)
  20. Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR ≥1.5 within 14 days before enrollment)
  21. Uncontrolled hypertension
  22. Urine dipstick for proteinuria >+2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303495


Contacts
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Contact: Ruihua Xu, MD, PhD 87343333 xurh@sysucc.org.cn

Locations
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China, Guangdong
Cancer center of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Rui-Hua Xu, MD, PhD    86-020-87343333    xurh@sysucc.org.cn   
Contact: De-shen Wang, MD, PhD    86-020-87343351    wangdsh@sysucc.org.cn   
Sub-Investigator: De-shen Wang, MD, PhD         
Principal Investigator: Rui-hua Xu, MD, PhD         
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Ruihua Xu, Professor and President, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03303495     History of Changes
Other Study ID Numbers: RECHANGE
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

Keywords provided by Ruihua Xu, Sun Yat-sen University:
FOLFIRI
CPT-11
Bevacizumab
2nd-line metastatic colorectal cancer

Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Intestinal Neoplasms
Neoplasms by Site
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Bevacizumab
Irinotecan
Fluorouracil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic