Efficacy And Safety Of Xeliri + Avastin Followed By Xelox + Avastin Or Reverse Sequence In Metastatic Colorectal Cancer
NCT ID: NCT02119026
Last Updated: 2019-09-25
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-02-28
Study Completion Date
2017-08-31
Brief Summary
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Since its introduction, 5-fluorouracil (5-FU) has been the cornerstone of treatment for metastatic colorectal cancer (mCRC). Meanwhile the oral 5FU pro-drug Capecitabine (Xeloda®) proved equivalence to 5-FU and is a well tolerated alternative combination partner for Irinotecan (XELIRI) or Oxaliplatin (XELOX) which are widely used for first line treatment of mCRC. Recent advances in molecular biology have resulted in the development of an inhibitor of the vascular endothelial growth factor (VEGF) by the monoclonal humanized antibody bevacizumab (Avastin®).
XELOX or XELIRI +bevacizumab have been investigated in several trials, but not in an approach with clearly defined cross-wise XELIRI-XELOX change criteria. This trial investigates two different sequential treatment options with XELIRI/ XELOX in first and second line with the addition of bevacizumab and tries to give answer to the question if there is an optimal sequence for the benefit of the patient.
This is a prospective, randomized, open-label, 2-arm pilot trial in patients with mCRC who did not receive systemic treatment for their metastatic disease. The study is designed to evaluate the efficacy of XELIRI followed by XELOX and XELOX followed by XELIRI + bevacizumab in terms of Duration of Disease Control (DDC).
Patients will be treated with an established first line therapy consisting of either XELOX or XELIRI + bevacizumab. The chemotherapy treatment will be given for 6 months except prior disease progression, unacceptable toxicity or patient refusal. Bevacizumab will be given until disease progression, unacceptable toxicity or patient refusal.
Capecitabine can be given in addition at the investigators' discretion until disease progression, unacceptable toxicity or patient refusal.
If serious side effects occur despite adequate dose reduction, Oxaliplatin or Irinotecan should be discontinued. In case of Oxaliplatin or Irinotecan-related discontinuation Capecitabine and Bevacizumab should be continued. If Capecitabine also has to be discontinued in first line treatment bevacizumab should be continued. In case of permanent discontinuation of bevacizumab for toxicities, chemotherapy should be continued.
Upon completion of first line chemotherapy patients with disease control will receive bevacizumab maintenance treatment. On investigators decision patients can receive Capecitabine as additional maintenance treatment.
The primary endpoint is to determine the efficacy of a modified XELIRI + bevacizumab followed by XELOX + bevacizumab scheme at progression in comparison with the reverse sequence based on DDC.
Secondary endpoints are first line progression-free survival (PFS), second line PFS, overall response rate, time to response, duration of response, overall survival, tumor assessments (based on RECIST criteria) using CT scans, MRI scans, X-ray, bone scan, clinical examination.
XELOX or XELIRI +bevacizumab have been investigated in several trials, but not in an approach with clearly defined cross-wise XELIRI-XELOX change criteria. This trial investigates two different sequential treatment options with XELIRI/ XELOX in first and second line with the addition of bevacizumab and tries to give answer to the question if there is an optimal sequence for the benefit of the patient.
This is a prospective, randomized, open-label, 2-arm pilot trial in patients with mCRC who did not receive systemic treatment for their metastatic disease. The study is designed to evaluate the efficacy of XELIRI followed by XELOX and XELOX followed by XELIRI + bevacizumab in terms of Duration of Disease Control (DDC).
Patients will be treated with an established first line therapy consisting of either XELOX or XELIRI + bevacizumab. The chemotherapy treatment will be given for 6 months except prior disease progression, unacceptable toxicity or patient refusal. Bevacizumab will be given until disease progression, unacceptable toxicity or patient refusal.
Capecitabine can be given in addition at the investigators' discretion until disease progression, unacceptable toxicity or patient refusal.
If serious side effects occur despite adequate dose reduction, Oxaliplatin or Irinotecan should be discontinued. In case of Oxaliplatin or Irinotecan-related discontinuation Capecitabine and Bevacizumab should be continued. If Capecitabine also has to be discontinued in first line treatment bevacizumab should be continued. In case of permanent discontinuation of bevacizumab for toxicities, chemotherapy should be continued.
Upon completion of first line chemotherapy patients with disease control will receive bevacizumab maintenance treatment. On investigators decision patients can receive Capecitabine as additional maintenance treatment.
The primary endpoint is to determine the efficacy of a modified XELIRI + bevacizumab followed by XELOX + bevacizumab scheme at progression in comparison with the reverse sequence based on DDC.
Secondary endpoints are first line progression-free survival (PFS), second line PFS, overall response rate, time to response, duration of response, overall survival, tumor assessments (based on RECIST criteria) using CT scans, MRI scans, X-ray, bone scan, clinical examination.
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Detailed Description
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Conditions
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Metastatic Colorectal Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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A: XELIRI + BEV Followed by XELOX + BEV
capecitabine and irinotecan (XELIRI) plus bevacizumab (AVASTIN; BEV)
Capecitabine : 800mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on day 1 q3w combined with irinotecan 200mg/m2 iv. d 1 q3w . Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression irinotecan will be replaced by oxaliplatin (arm A). Bevacizumab will be continued.
Group Type
ACTIVE_COMPARATOR
Capecitabine
Intervention Type
DRUG
800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Bevacizumab
Intervention Type
DRUG
7,5 mg/kg given on d1 q3w
Irinotecan
Intervention Type
DRUG
200mg/m2 iv. d 1 q3w .
B: XELOX + BEV followed by XELIRI + BEV
capecitabine and oxaliplatin (XELOX) plus bevacizumab (Avastin; BEV)
Arm B:
Capecitabine: 1000mg/m2 bid d1-14, bevacizumab 7,5 mg/kg given on d1 q3w combined with oxaliplatin 130mg/m2 iv. d 1 q3w Bevacizumab (7.5 mg/kg q3w) ± Capecitabine (1000 mg/m2 bid, days 1-14 q3w) maintenance
At disease progression oxaliplatin will be replaced by irinotecan (arm B). Bevacizumab will be continued.
Group Type
ACTIVE_COMPARATOR
Capecitabine
Intervention Type
DRUG
1000mg/m2 bid d1-14,
Bevacizumab
Intervention Type
DRUG
7,5 mg/kg given on d1 q3w
Oxaliplatin
Intervention Type
DRUG
130mg/m2 iv. d 1 q3w
Interventions
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Capecitabine
800mg/m2 bid d1-14
± 1000 mg/m2 bid,days 1-14 q3w: maintenance
Intervention Type
DRUG
Capecitabine
1000mg/m2 bid d1-14,
Intervention Type
DRUG
Bevacizumab
7,5 mg/kg given on d1 q3w
Intervention Type
DRUG
Oxaliplatin
130mg/m2 iv. d 1 q3w
Intervention Type
DRUG
Irinotecan
200mg/m2 iv. d 1 q3w .
Intervention Type
DRUG
Other Intervention Names
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Brand Name: Xeloda
Brand name: Xeloda
Brand name: Avastin
Eligibility Criteria
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Inclusion Criteria
1. Written informed consent
2. Age \>=18 years
3. Patient must be able to comply with the protocol
4. Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases. 5 )Diagnosis of metastatic disease according to Response Evaluation Criteria in Solid Tumours (RECIST) not more than 3 months prior to enrolment.
6\) Life Expectancy of at least 3 months 7) At least one measurable metastatic lesion (as per RECIST criteria) 8) Prior adjuvant or neo-adjuvant chemotherapy/radiotherapy allowed if completed more than 6 months before inclusion. 9) Eastern Collaborative Oncology Group (ECOG) performance score of 0 or 1 10) Adequate haematological function: absolute neutrophil count (ANC) \>= 1.5 x 109/L; platelets \>= 100 x 109/L, Hb \>= 9 g/dL 11) international normalized ratio (INR) \<=1.5 and activated partial thromboplastin time (aPTT) \<=1.5 x ULN within 7 days prior to starting study treatment 12) Adequate liver function: Serum bilirubin \<=1.5 x ULN; alkaline phosphatase and transaminases \<=2.5 x ULN (in case of liver metastases \< 5 x ULN) 13) Serum Creatinine \<=1.5 x ULN 14) Urine dipstick for proteinuria \< 2+. If urine dipstick is \>= 2+, 24- hour urine must demonstrate \<=1 g of protein in 24 hours 15) Negative serum pregnancy test within 7 days of starting study treatment in pre- menopausal women and women \< 2 years after the onset of menopause. This test has to be reconfirmed by a urine test, should the 7 days window be exceeded. Fertile women (\<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
2. Age \>=18 years
3. Patient must be able to comply with the protocol
4. Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases. 5 )Diagnosis of metastatic disease according to Response Evaluation Criteria in Solid Tumours (RECIST) not more than 3 months prior to enrolment.
6\) Life Expectancy of at least 3 months 7) At least one measurable metastatic lesion (as per RECIST criteria) 8) Prior adjuvant or neo-adjuvant chemotherapy/radiotherapy allowed if completed more than 6 months before inclusion. 9) Eastern Collaborative Oncology Group (ECOG) performance score of 0 or 1 10) Adequate haematological function: absolute neutrophil count (ANC) \>= 1.5 x 109/L; platelets \>= 100 x 109/L, Hb \>= 9 g/dL 11) international normalized ratio (INR) \<=1.5 and activated partial thromboplastin time (aPTT) \<=1.5 x ULN within 7 days prior to starting study treatment 12) Adequate liver function: Serum bilirubin \<=1.5 x ULN; alkaline phosphatase and transaminases \<=2.5 x ULN (in case of liver metastases \< 5 x ULN) 13) Serum Creatinine \<=1.5 x ULN 14) Urine dipstick for proteinuria \< 2+. If urine dipstick is \>= 2+, 24- hour urine must demonstrate \<=1 g of protein in 24 hours 15) Negative serum pregnancy test within 7 days of starting study treatment in pre- menopausal women and women \< 2 years after the onset of menopause. This test has to be reconfirmed by a urine test, should the 7 days window be exceeded. Fertile women (\<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
Exclusion Criteria
1. Prior chemotherapeutic treatment for metastatic CRC
2. Symptomatic central nervous system (CNS) metastases
3. Significant vascular disease (e.g. aortic aneurysm potentially requiring surgical intervention, pulmonary embolism or recent peripheral arterial thrombosis) within 6 months prior start of study treatment.
4. History of haemoptysis (= a half teaspoon of bright red blood per episode) within 1 month prior start of study treatment
5. Past or current history (within the last 2 years prior to treatment start) of other malignancies (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
6. Clinically significant cardiovascular disease, for example central venous access (CVA) (\<=6 months before treatment start), myocardial infarction (\<=6 months before treatment start), unstable angina, New York Heart Association (NYHA) \>= grade 2, congestive heart failure (CHF), arrhythmia requiring medication, or uncontrolled hypertension.
7. Prior history of hypertensive crisis or hypertensive encephalopathy
8. Treatment with any other investigational agent or any other biological agent (e.g.cetuximab), or participation in another clinical trial within 30 days prior to entering this study.
9. Known hypersensitivity to any of the study drugs
10. Current or recent (within 10 days of first dose of study treatment) chronic use of aspirin (\> 325 mg/day)
11. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes.
12. Evidence of bleeding diathesis or coagulopathy.
13. Serious, non healing wound, ulcer, or bone fracture.
14. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study. If central venous access device (CVAD) is required for chemotherapy administration, it should be inserted within 2 days prior to study treatment cycle.
15. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior start of study therapy
16. History of abdominal fistula, trachea-oesophageal fistula or any grade 4 non gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess before 1st line therapy.
17. History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures
18. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications
19. Patients with contraindication for cross over chemotherapy (e.g. patients treated with irinotecan based first line therapy and serious polyneuropathy \> grade 1, not feasible for oxaliplatin based cross over second line therapy, or patients treated with oxaliplatin based first line therapy and hereditary fructose intolerance not feasible for Irinotecan based cross over second line therapy)
20. Pregnancy or lactation
21. Fertile women (\<2 years after last menstruation) and men not willing to use effective means of contraception.
2. Symptomatic central nervous system (CNS) metastases
3. Significant vascular disease (e.g. aortic aneurysm potentially requiring surgical intervention, pulmonary embolism or recent peripheral arterial thrombosis) within 6 months prior start of study treatment.
4. History of haemoptysis (= a half teaspoon of bright red blood per episode) within 1 month prior start of study treatment
5. Past or current history (within the last 2 years prior to treatment start) of other malignancies (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
6. Clinically significant cardiovascular disease, for example central venous access (CVA) (\<=6 months before treatment start), myocardial infarction (\<=6 months before treatment start), unstable angina, New York Heart Association (NYHA) \>= grade 2, congestive heart failure (CHF), arrhythmia requiring medication, or uncontrolled hypertension.
7. Prior history of hypertensive crisis or hypertensive encephalopathy
8. Treatment with any other investigational agent or any other biological agent (e.g.cetuximab), or participation in another clinical trial within 30 days prior to entering this study.
9. Known hypersensitivity to any of the study drugs
10. Current or recent (within 10 days of first dose of study treatment) chronic use of aspirin (\> 325 mg/day)
11. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes.
12. Evidence of bleeding diathesis or coagulopathy.
13. Serious, non healing wound, ulcer, or bone fracture.
14. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study. If central venous access device (CVAD) is required for chemotherapy administration, it should be inserted within 2 days prior to study treatment cycle.
15. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior start of study therapy
16. History of abdominal fistula, trachea-oesophageal fistula or any grade 4 non gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess before 1st line therapy.
17. History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures
18. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications
19. Patients with contraindication for cross over chemotherapy (e.g. patients treated with irinotecan based first line therapy and serious polyneuropathy \> grade 1, not feasible for oxaliplatin based cross over second line therapy, or patients treated with oxaliplatin based first line therapy and hereditary fructose intolerance not feasible for Irinotecan based cross over second line therapy)
20. Pregnancy or lactation
21. Fertile women (\<2 years after last menstruation) and men not willing to use effective means of contraception.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Prof. Dr. Werner Scheithauer
OTHER
Sponsor Role
lead
Responsible Party
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Prof. Dr. Werner Scheithauer
Prof. Dr.
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Werner Scheithauer, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Medical University of Vienna
Vienna, , Austria
Site Status
Countries
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Austria
References
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Arnold D, Petersen , Kindler M, et al. Patterns of maintenance treatment (Tx) following firstline bevacizumab (bev) plus chemotherapy (CT) for metastatic colorectal cancer (mCRC): Results from a large German community-based cohort study. J Clin Oncol 29: 2011 (suppl 4; abstr 502)
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BACKGROUND
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BACKGROUND
Yalcin S, Uslu R, Dane F, et al. A Randomized, multicenter phase III trial of bevacizumab plus capecitabine were given as maintenance treatment after initial treatment with bevacizumab plus XELOX in previously untreated metastatic colorectal cancer. J Clin Oncol 29: 2011 (suppl 4; abstr 474)
Reference Type
BACKGROUND
Warren RS, Yuan H, Matli MR, Gillett NA, Ferrara N. Regulation by vascular endothelial growth factor of human colon cancer tumorigenesis in a mouse model of experimental liver metastasis. J Clin Invest. 1995 Apr;95(4):1789-97. doi: 10.1172/JCI117857.
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Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004 Jan 15;22(2):229-37. doi: 10.1200/JCO.2004.05.113. Epub 2003 Dec 2.
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BACKGROUND
The Criteria Committee of the New York Heart Association. Diseases of the Heart and Blood Vessels: Nomenclature and Criteria for Diagnosis. 6th ed. Boston, MA: Little Brown, 1964
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BACKGROUND
Tabernero J, Aranda E, Gomez A, et al. Phase III study of first-line XELOX plus bevacizumab (BEV) for 6 cycles followed by XELOX plus BEV or single-agent (s/a) BEV as maintenance therapy in patients (pts) with metastatic colorectal cancer (mCRC): The MACRO Trial (Spanish Cooperative Group for the Treatment of Digestive Tumors [TTD]). Clin Oncol 28:7s, 2010 (suppl; abstr 3501), Abstract No: 3501
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BACKGROUND
Souglakos J, Androulakis N, Syrigos K, Polyzos A, Ziras N, Athanasiadis A, Kakolyris S, Tsousis S, Kouroussis Ch, Vamvakas L, Kalykaki A, Samonis G, Mavroudis D, Georgoulias V. FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG). Br J Cancer. 2006 Mar 27;94(6):798-805. doi: 10.1038/sj.bjc.6603011.
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BACKGROUND
Simmonds PC. Palliative chemotherapy for advanced colorectal cancer: systematic review and meta-analysis. Colorectal Cancer Collaborative Group. BMJ. 2000 Sep 2;321(7260):531-5. doi: 10.1136/bmj.321.7260.531.
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BACKGROUND
Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Cassidy J. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008 Apr 20;26(12):2013-9. doi: 10.1200/JCO.2007.14.9930.
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A. C. Reinacher-Schick, S. Kubicka, W. Freier, et al. Activity of the combination of bevacizumab (Bev) with capecitabine/irinotecan (CapIri/Bev) or capecitabine/oxaliplatin (CapOx/Bev) in advanced colorectal cancer (ACRC): A randomized phase II study of the AIO Colorectal Study Group (AIO trial 0604). J Clin Oncol 26: 2008 (May 20 suppl; abstr 4030)
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BACKGROUND
Mabro M, Artru P, Andre T, Flesch M, Maindrault-Goebel F, Landi B, Lledo G, Plantade A, Louvet C, de Gramont A. A phase II study of FOLFIRI-3 (double infusion of irinotecan combined with LV5FU) after FOLFOX in advanced colorectal cancer patients. Br J Cancer. 2006 May 8;94(9):1287-92. doi: 10.1038/sj.bjc.6603095.
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BACKGROUND
Koopman M, Antonini NF, Douma J, Wals J, Honkoop AH, Erdkamp FL, de Jong RS, Rodenburg CJ, Vreugdenhil G, Loosveld OJ, van Bochove A, Sinnige HA, Creemers GM, Tesselaar ME, Slee PHTJ, Werter MJ, Mol L, Dalesio O, Punt CJ. Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial. Lancet. 2007 Jul 14;370(9582):135-142. doi: 10.1016/S0140-6736(07)61086-1.
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Kim KJ, Li B, Winer J, Armanini M, Gillett N, Phillips HS, Ferrara N. Inhibition of vascular endothelial growth factor-induced angiogenesis suppresses tumour growth in vivo. Nature. 1993 Apr 29;362(6423):841-4. doi: 10.1038/362841a0.
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Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.
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BACKGROUND
Hedrick E, Kozloff M, Hainsworth J, et al. Safety of bevacizumab plus chemotherapy as firstline treatment of patients with metastatic colorectal cancer: Updated results from a large observational registry in the US (BRiTE). J Clin Oncol 2006;24:Abstract 3536.
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Grothey A, Sargent D, Goldberg RM, Schmoll HJ. Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol. 2004 Apr 1;22(7):1209-14. doi: 10.1200/JCO.2004.11.037.
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BACKGROUND
Gerber HP, Ferrara N. Pharmacology and pharmacodynamics of bevacizumab as monotherapy or in combination with cytotoxic therapy in preclinical studies. Cancer Res. 2005 Feb 1;65(3):671-80.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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http://ethikkommission.meduniwien.ac.at/
ethical review committee
http://www.basg.gv.at
Regulatory authority Austria
http://www.meduniwien.ac.at/innere-med-1/onkologie/
Medical University Vienna/Clin. Division of Oncology
Other Identifiers
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ML25153_PASSION
Identifier Type: -
Identifier Source: org_study_id
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Capecitabine, Cetuximab, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Removed By Surgery
NCT00290615
COMPLETED
PHASE2
Phase II Study to Evaluate Safety and Efficacy of Cetuximab in Combination With XELOX for 12 Weeks Followed by Maintenance Treatment With Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer.
NCT00531115
TERMINATED
PHASE2
Study of Bevacizumab Alone or Combined With Capecitabine and Oxaliplatin as Support Therapy in Metastatic Colorectal Cancer Patients
NCT00335595
COMPLETED
PHASE3
Bevacizumab Plus Capecitabine (Xeloda) in Patients With Untreated Metastatic Colorectal Cancer
NCT00203411
COMPLETED
PHASE2
Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC
NCT00755534
TERMINATED
PHASE2
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
NCT00048139
COMPLETED
PHASE2
A Study of Bevacizumab Plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer
NCT04324476
UNKNOWN
PHASE2