A RANDOMIZED, PHASE 2B STUDY OF SUNITINIB PLUS OXALIPLATIN, 5-FLUOROURACIL AND LEUCOVORIN (FOLFOX) VERSUS BEVACIZUMAB PLUS FOLFOX AS FIRST-LINE TREATMENT IN PATIENTS WITH METASTATIC COLORECTAL CANCER - n/a

• Register: EUCTR
• Last refreshed on: 21 January 2013
• Main ID: EUCTR2007-002987-84-DE
• Date of registration: 10/04/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc. 235 East 42nd Street, NEW YORK, NY 10017. US
• Public title: A RANDOMIZED, PHASE 2B STUDY OF SUNITINIB PLUS OXALIPLATIN, 5-FLUOROURACIL AND LEUCOVORIN (FOLFOX) VERSUS BEVACIZUMAB PLUS FOLFOX AS FIRST-LINE TREATMENT IN PATIENTS WITH METASTATIC COLORECTAL CANCER - n/a
• Scientific title: A RANDOMIZED, PHASE 2B STUDY OF SUNITINIB PLUS OXALIPLATIN, 5-FLUOROURACIL AND LEUCOVORIN (FOLFOX) VERSUS BEVACIZUMAB PLUS FOLFOX AS FIRST-LINE TREATMENT IN PATIENTS WITH METASTATIC COLORECTAL CANCER - n/a
• Date of first enrolment: 31/07/2008
• Target sample size: 290
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002987-84
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Denmark, Germany

Key inclusion & exclusion criteria

Inclusion criteria:
1. Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with locally advanced or documented metastatic disease.
2. Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
3. 18 years of age or older.
4. ECOG performance status 0 or 1.
5. Resolution of all acute toxic effects of prior therapy (except for alopecia) or surgical procedure to NCI CTCAE v.3.0 grade =1.
6. Adequate organ function as defined by the following criteria:
• Serum aspartate aminotransferase (AST; serum glutamic oxaloacetic transaminase[SGOT]) and serum alanine aminotransferase (ALT; serum glutamic pyruvic
transaminase [SGPT]) =2.5 x upper limit of normal (ULN), =5 x ULN for patients with liver metastases
• Total serum bilirubin =1.5 x ULN
• Serum albumin =3.0 g/dL
• Absolute neutrophil count (ANC) =1500/µL
• Platelets =100,000/µL
• Hemoglobin =9.0 g/dL
• Serum creatinine =1.5 x ULN
• Left ventricular ejection fraction (LVEF) =lower limit of institutional normal (LLN) as assessed by multigated acquisition (MUGA) scan or echocardiogram (ECHO).
7. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the completion of patient reported outcome measures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Prior treatment with sunitinib, bevacizumab, or any other systemic therapy (including other investigational agents) for locally advanced or metastatic colorectal cancer.
2. Current treatment on another therapeutic clinical trial.
3. Less than 6 months from the time of completion of adjuvant chemotherapy to the time of diagnosis or documentation of recurrent or metastatic cancer for those patients who have received adjuvant treatment after resection of early-stage colorectal cancer.
4. Less than 4 weeks from completion of adjuvant radiation therapy for resected rectal cancer and other palliative radiotherapy to non-target, metastatic lesions.
5. Prior radiotherapy to >30% of bone marrow.
6. Prior surgery within 4 weeks of study entry.
7. Presence of grade =2 peripheral neuropathy.
8. Known dihydropyrimidine dehydrogenase deficiency or severe hypersensitivity reaction to 5-FU.
9. History of clinically significant bleeding within the past 6 months, including gross
hemoptysis or hematuria, or underlying coagulopathy.
10. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment, unless affected area has been removed
surgically.
11. Ongoing cardiac dysrhythmias of grade =2 or QTc interval to >450 msec for males and >470 msec for females.
12. Ongoing treatment with therapeutic levels of coumarin derivatives or oral anti-vitamin K agents.
13. Hypertension that cannot be controlled by medication (>150/100 mmHg despite optimal medical therapy).
14. Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated without evidence of recurrent disease for 12 months.
15. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI scan.
16. Any of the following within the 6 months prior to study drug administration: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, pulmonary embolism, cerebrovascular accident, or transient ischemic attack.
17. Known human immunodeficiency virus (HIV) infection.
18. Pregnancy or breastfeeding. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) prior to the start of the study.
19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

METASTATIC COLORECTAL CANCER
MedDRA version: 9.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer

Intervention(s)

Trade Name: SUTENT
Product Code: SU011248 L-Malate Salt
Pharmaceutical Form: Capsule, hard
CAS Number: 341031-54-7
Current Sponsor code: SU011248
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-

Trade Name: SUTENT
Product Code: SU011248 L-Malate Salt
Pharmaceutical Form: Capsule, hard
CAS Number: 341031-54-7
Current Sponsor code: SU011248
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Product Code: SU011248 L-Malate Salt
Pharmaceutical Form: Capsule, hard
CAS Number: 341031-54-7
Current Sponsor code: SU011248
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 37.5-

Trade Name: SUTENT
Product Code: SU011248 L-Malate Salt
Pharmaceutical Form: Capsule, hard
CAS Number: 341031-54-7
Current Sponsor code: SU011248
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Avastin
Pharmaceutical Form: Powder and solvent for solution for infusion
CAS Number: 216974-75-3
Current Sponsor code: Bevacizumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Avastin
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 216974-75-3
Current Sponsor code: Bevacizumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Product Name: 5-Fourouracil
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: 5-Fluorouracil
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Product Name: Leucovorin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Folinic acid
Other descriptive name: leucovorin (USAN),
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Eloxatin 5 mg/ml Konzentrat
Product Name: Oxaliplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Oxaliplatin
C

Primary Outcome(s)

Main Objective: To demonstrate an improvement in progression-free survival (PFS) in patients with
mCRC treated with sunitinib plus FOLFOX compared with bevacizumab plus
FOLFOX in the first-line treatment setting.

Primary end point(s): Progression-free survival (PFS)

Secondary Objective: To compare the overall survival (OS) in patients with mCRC treated with sunitinib
plus FOLFOX versus bevacizumab plus FOLFOX in the first-line treatment setting.
To compare the objective response rate (ORR) and duration of response (DR) in
patients with mCRC treated with sunitinib plus FOLFOX versus bevacizumab plus
FOLFOX in the first-line treatment setting.
To compare patient reported outcomes (PROs) of patients with mCRC treated with
sunitinib plus FOLFOX versus bevacizumab plus FOLFOX in the first-line treatment
setting.To compare the safety and tolerability of sunitinib plus FOLFOX versus that of the
bevacizumab plus FOLFOX combination.

Secondary ID(s)

n/a

A6181104