Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer

Browse trials for

• Colorectal Neoplasms 5,598

Keywords

• metastatic
• stage IV

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's enrollment of 230 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Lead sponsor

National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.

Study arms

• Experimental
  bevacizumab before chemotherapy

  Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)

  Drug: Bevacizumab · Drug: Oxaliplatin · Drug: levo-folinic acid · Drug: 5-fluorouracil · Drug: Capecitabine

• Active comparator
  bevacizumab with chemotherapy

  Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)

  Drug: Bevacizumab · Drug: Oxaliplatin · Drug: levo-folinic acid · Drug: 5-fluorouracil · Drug: Capecitabine

Interventions

• DrugBevacizumab

  5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.

  Also known as: Avastin

• DrugOxaliplatin

  85mg/m2 IV every 2 weeks for up to 24 weeks

  Also known as: Eloxatin

• Druglevo-folinic acid

  200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks

  Also known as: Lederfolin

• Drug5-fluorouracil

  400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)

  Also known as: Fluorouracil

• DrugCapecitabine

  1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)

  Also known as: Xeloda

Primary outcomes

1. Objective Response Rate

   Objective response rate (ORR), according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, was the primary end point and was defined as the number of complete plus partial responses divided by the number of enrolled patients. Per RECIST v 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

   Time frame: Objective response was assessed by computed tomographic scan or other appropriate imaging at weeks 12 and 24 from randomization, and every 3 months thereafter, assessed up to 90 months.

Secondary outcomes

1. Disease Control Rate

   Disease control rate was calculated by adding complete and partial responses and stable disease.

   Time frame: At weeks 12 and 24 from randomization and every 3 months thereafter, assessed up to 90 months

2. Overall Survival

   Overall survival was defined as the time from randomization to the date of death. Patients alive at the time of the final analysis were censored on the date of the last follow-up information available.

   Time frame: assessed up to 90 months

3. Progression-free Survival (PFS)

   Progression-free survival was defined as the time from randomization to the date of progression or death, whichever occurred first. Patients without progression were censored on the date of the last follow-up visit. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

   Time frame: assessed up to 90 months

4. Toxic Effects

   Toxic effects were scored according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. For the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 scale score range from 1 to 4. A high score, that is 3 and 4, represents a high level of toxicity, whereas the minimum values, that is 1 and 2, represents a mild/modest level of toxicity.

   Time frame: up to 4 weeks after the end of the treatment

Baseline characteristics

Publications

• Avallone A, Piccirillo MC, Nasti G, Rosati G, Carlomagno C, Di Gennaro E, Romano C, Tatangelo F, Granata V, Cassata A, Silvestro L, De Stefano A, Aloj L, Vicario V, Nappi A, Leone A, Bilancia D, Arenare L, Petrillo A, Lastoria S, Gallo C, Botti G, Delrio P, Izzo F, Perrone F, Budillon A. Effect of Bevacizumab in Combination With Standard Oxaliplatin-Based Regimens in Patients With Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2118475. doi: 10.1001/jamanetworkopen.2021.18475. PubMed 34309665 ↗
• Avallone A, Piccirillo MC, Aloj L, Nasti G, Delrio P, Izzo F, Di Gennaro E, Tatangelo F, Granata V, Cavalcanti E, Maiolino P, Bianco F, Aprea P, De Bellis M, Pecori B, Rosati G, Carlomagno C, Bertolini A, Gallo C, Romano C, Leone A, Caraco C, de Lutio di Castelguidone E, Daniele G, Catalano O, Botti G, Petrillo A, Romano GM, Iaffaioli VR, Lastoria S, Perrone F, Budillon A. A randomized phase 3 study on the optimization of the combination of bevacizumab with FOLFOX/OXXEL in the treatment of patients with metastatic colorectal cancer-OBELICS (Optimization of BEvacizumab scheduLIng within Chemotherapy Scheme). BMC Cancer. 2016 Feb 8;16:69. doi: 10.1186/s12885-016-2102-y. PubMed 26857924 ↗

Study documents

• Protocol and statistical analysis plan · Oct 6, 2011

Documents are hosted by the registry — open the source record to download them.