Axitinib as Maintenance Treatment in Patients With Metastatic CRC

NCT01483638 | Terminated Phase 2

• 2 other identifiers: TTD-11-012011-002384-16
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the maintenance therapy with axitinib in patients with metastatic colorectal carcinoma

Conditions

Colorectal Carcinoma

Keywords

duration of disease response; axitinib

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  4 years

Secondary Outcomes (4)

• overall survival

  4 years

• overall response rate

  4 years

• duration of disease response

  4 years

• Adverse events

  4 years

Study Arms (2)

Experimental

EXPERIMENTAL

axitinib

Drug: axitinib

control

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

axitinib DRUG

5 mg BID taken orally with food continuously on Day 1 of the study. One cycle corresponds to 28 days.

Experimental

placebo DRUG

will be administered orally with the same schedule of axitinib

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have histological or cytological confirmed colorectal adenocarcinoma with metastatic disease documented on diagnostic imaging studies, not susceptible of radical surgery of metastases, and a low burden of disease.
• Patients without progressive disease after six months of the standard first line chemotherapy regimen for CRC (5FU or capecitabine ± oxaliplatin or irinotecan ± bevacizumab or cetuximab).
• Patient must have at least one measurable lesion as defined by modified RECIST criteria.
• Male or female, age ≥18 years.
• ECOG performance status of 0 or 1 and life expectancy of ≥12 weeks.
• Adequate organ function as defined by the following criteria:
• absolute neutrophil count (ANC) ≥1500 cells/mm3;
• platelets ≥100,000 cells/mm3.
• Hemoglobin ≥9.0 g/dL.
• AST and ALT ≤2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT ≤5.0 x ULN;
• Total bilirubin ≤1.5 x ULN;
• Alkaline phosphatase \<300U/l
• Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥50 mL/min;
• Urinary protein \<2+ by urine dipstick. If dipstick is ≥2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is \<2 g per 24 hours.
• At least 4 weeks since the end of prior systemic treatment, radiotherapy, or surgical procedure with resolution of all treatment-related toxicity to NCI CTCAE Version 4.0 grade ≤1 or back to baseline except for alopecia or neurotoxicity

You may not qualify if:

• Gastrointestinal abnormalities including:
• inability to take oral medication;
• requirement for intravenous alimentation;
• prior surgical procedures affecting absorption including total gastric resection;
• treatment for active peptic ulcer disease in the past 6 months;
• active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
• malabsorption syndromes.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to start, unless affected area has been removed surgically
• Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine).
• Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort).
• History of haemorrhage within the past 6 months, including gross hemoptysis or hematuria.
• Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
• Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
• A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
• Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.

Sponsors & Collaborators

• Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD): lead

Study Sites (1)

Spanish Cooperative Group for Digestive Tumour Therapy

Madrid, Madrid, 28046, Spain

Location

Related Links

• Related info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Cristina Grávalos, MD

  Hospital 12 de Octubre

  STUDY CHAIR

• Alfredo Carrato, MD, PhD

  Hospital Universitario Ramon y Cajal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 1, 2011
• Study Start: February 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

ES (1)