Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

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Bevacizumab

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Sunitinib

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Folinic Acid

Treatment arm A - sunitinib plus mFOLFOX6

Treatment arm B - bevacizumab plus mFOLFOX6

Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).

sunitinib

FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle

mFOLFOX6

Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.

bevacizumab

Pfizer CT.gov Call Center

This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer who have not been treated before.

The study was terminated on April 26, 2010 due to lack of efficacy, as determined during the interim analysis of data in April 2010, showing that the study did not meet its primary endpoint to demonstrate a statistically significant improvement in PFS. The decision to terminate the trial was not based on any safety concerns.

Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer

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

Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").

Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.

Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment.

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

FACT-C used for assessment of health-related quality of life (QoL) in participants with cancer. It consists of 36 items, summarized to 5 subscales:physical well-being (PWB) (7 items), functional well-being (FWB) (7 items), social/family well-being (SWB) (7 items); all 3 subscales range from 0 to 28, emotional well-being (EWB) (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.

FACT\&GOG-Ntx has a 13-item, treatment-specific subscale for patients with neurotoxicity. It is the sum of the PWB (7 items), FWB (7 items), SWB (7 items) and EWB (6 items) subscales plus a 13 item neurotoxicity subscale. Subscale score ranges from 0 to 28 for PWB, FWB, SWB, 0 to 24 for EWB and 0 to 52 for neurotoxicity subscale. Total possible score range is 0 to 160. Higher scores indicates better QoL, fewer disease symptoms, and/or fewer side effects of treatment and lower scores indicate worse QoL and a greater impact of disease symptoms and/or side effects.

Pfizer

Same event may appear as both AE and SAE. But distinct events are presented. Event may be serious in 1 subject and nonserious in another, or 1 subject may have both serious, nonserious event. At risk population=participants with metastatic colorectal cancer, with at least 1 dose of study medication; Sunitinib+mFOLFOX6=96, Bevacizumab+mFOLFOX6=93.

Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m\^2 and leucovorin 400 mg/m\^2 (or levo-leucovorin 200 mg/m\^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m\^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m\^2 on Days 1 and 2 of each 2 week cycle.

Sunitinib + mFOLFOX6

Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m\^2 and leucovorin 400 mg/m\^2 (or levo-leucovorin 200 mg/m\^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m\^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m\^2 on Days 1 and 2 of each 2 week cycle.

Bevacizumab + mFOLFOX6

Total

Age Continuous

Sex: Female, Male

Due to early study termination, not all data was analyzable.

Pfizer ClinicalTrials.gov Call Center

P-value was calculated from a 1-sided, log-rank test stratified for Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), Baseline Lactate Dehydrogenase (LDH): greater than (\>) 1.5 vs. less than or equal to (\<=) 1.5 \* upper limit of normal range (ULN), and Prior Adjuvant Treatment (yes vs. no).

The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.

Progression-free Survival (PFS)

P-value was calculated from a 1-sided, log-rank test stratified for ECOG Performance Status (0 vs. 1), Baseline LDH: \>1.5 vs. \<=1.5 \* ULN, and Prior Adjuvant Treatment (yes vs. no).

The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.

Overall Survival (OS)

Data was not analyzed due to early study termination.

One Year Survival Probability

Two Year Survival Probability

Percentage of Participants With Objective Response (OR)

Duration of Response (DR)

Differences in PWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.

Differences in PWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.

Differences in PWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.

Differences in PWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.

Differences in PWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.

Differences in PWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.

Differences in PWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.

Differences in PWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.

Differences in PWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.

Differences in PWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.

Differences in PWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.

Differences in PWB between treatment arms (EOT) was analyzed from a two-sample t-test.

Differences in SWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.

Differences in SWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.

Differences in SWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.

Differences in SWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.

Differences in SWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.

Differences in SWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.

Differences in SWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.

Differences in SWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.

Differences in SWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.

Differences in SWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.

Differences in SWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.

Differences in SWB between treatment arms (EOT) was analyzed from a two-sample t-test.

Differences in EWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.

Differences in EWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.

Differences in EWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.

Differences in EWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.

Differences in EWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.

Differences in EWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.

Differences in EWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.

Differences in EWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.

Differences in EWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.

Differences in EWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.

Differences in EWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.

Differences in EWB between treatment arms (EOT) was analyzed from a two-sample t-test.

Differences in FWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.

Differences in FWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.

Differences in FWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.

Differences in FWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.

Differences in FWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.

Differences in FWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.

Differences in FWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.

Differences in FWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.

Differences in FWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.

Differences in FWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.

Differences in FWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.

Differences in FWB between treatment arms (EOT) was analyzed from a two-sample t-test.

Differences in CCS between treatment arms (C4 of D1) was analyzed from a two-sample t-test.

Differences in CCS between treatment arms (C7 of D1) was analyzed from a two-sample t-test.

Differences in CCS between treatment arms (C10 of D1) was analyzed from a two-sample t-test.

Differences in CCS between treatment arms (C13 of D1) was analyzed from a two-sample t-test.

Differences in CCS between treatment arms (C16 of D1) was analyzed from a two-sample t-test.

Differences in CCS between treatment arms (C19 of D1) was analyzed from a two-sample t-test.

Differences in CCS between treatment arms (C22 of D1) was analyzed from a two-sample t-test.

Differences in CCS between treatment arms (C25 of D1) was analyzed from a two-sample t-test.

Differences in CCS between treatment arms (C28 of D1) was analyzed from a two-sample t-test.

Differences in CCS between treatment arms (C31 of D1) was analyzed from a two-sample t-test.

Differences in CCS between treatment arms (C34 of D1) was analyzed from a two-sample t-test.

Differences in CCS between treatment arms (EOT) was analyzed from a two-sample t-test.

PWB Baseline (n= 93, 90)

PWB Change at C4 D1 (n=80, 82)

PWB Change at C7 D1 (n=59, 75)

PWB Change at C10 D1 (n=45, 62)

PWB Change at C13 D1 (n=34, 40)

PWB Change at C16 D1 (n=25, 32)

PWB Change at C19 D1 (n=13, 23)

PWB Change at C22 D1 (n=6, 20)

PWB Change at C25 D1 (n=1, 15)

PWB Change at C28 D1 (n=1, 10)

PWB Change at C31 D1 (n=1, 4)

PWB Change at C34 D1 (n=1, 1)

PWB Change at C37 D1 (n=0, 1)

PWB Change at C40 D1 (n=0, 1)

PWB Change at C43 D1 (n=0, 1)

PWB Change at C46 D1 (n=0, 1)

PWB Change at C49 D1 (n=0, 1)

PWB Change at EOT (n=57, 43)

SWB Baseline (n=93, 88)

SWB Change at C4 D1 (n=80, 81)

SWB Change at C7 D1 (n=59, 73)

SWB Change at C10 D1 (n=45, 60)

SWB Change at C13 D1 (n=34, 39)

SWB Change at C16 D1 (n=25, 31)

SWB Change at C19 D1 (n=13, 23)

SWB Change at C22 D1 (n=6, 20)

SWB Change at C25 D1 (n=1, 15)

SWB Change at C28 D1 (n=1, 10)

SWB Change at C31 D1 (n=1, 4)

SWB Change at C34 D1 (n=1, 1)

SWB Change at C37 D1 (n=0, 1)

SWB Change at C 40 D1 (n=0, 1)

SWB Change at C43 D1 (n=0, 1)

SWB Change at C46 D1 (n=0, 1)

SWB Change at C49 D1 (n=0, 1)

SWB Change at EOT (n=57, 43)

EWB Baseline (n=93, 90)

EWB Change at C4 D1 (n=80, 82)

EWB Change at C7 D1 (n=59, 75)

EWB Change at C10 D1 (n=45, 62)

EWB Change at C13 D1 (n=34, 40)

EWB Change at C16 D1 (n=25, 32)

EWB Change at C19 D1 (n=13, 23)

EWB Change at C22 D1 (n=6, 20)

EWB Change at C25 D1 (n=1, 15)

EWB Change at C28 D1 (n=1, 10)

EWB Change at C31 D1 (n=1, 4)

EWB Change at C34 D1 (n=1, 1)

EWB Change at C37 D1 (n=0, 1)

EWB Change at C40 D1 (n=0, 1)

EWB Change at C43 D1 (n=0, 1)

EWB Change at C46 D1 (n=0, 1)

EWB Change at C49 D1 (n=0, 1)

EWB Change at EOT (n=57, 43)

FWB Baseline (n=93, 89)

FWB Change at C4 D1 (n=80, 81)

FWB Change at C7 D1 (n=59, 74)

FWB Change at C10 D1 (n=45, 61)

FWB Change at C13 D1 (n=34, 40)

FWB Change at C16 D1 (n=24, 31)

FWB Change at C19 D1 (n=13, 22)

FWB Change at C22 D1 (n=6, 19)

FWB Change at C25 D1 (n=1, 14)

FWB Change at C28 D1 (n=1, 9)

FWB Change at C31 D1 (n=1, 3)

FWB Change at C34 D1 (n=1, 1)

FWB Change at C37 D1 (n=0, 1)

FWB Change at C40 D1 (n=0, 1)

FWB Change at C43 D1 (n=0, 1)

FWB Change at C46 D1 (n=0, 1)

FWB Change at C49 D1 (n=0, 1)

FA set included participants randomized with study drug assignment, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. Here "n" signifies those participants evaluated for this measure at specific time point for each cohort respectively.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer	NCT00609622	Colorectal Neop...	sunitinib mFOLFOX6 bevacizumab mFOLFOX6	18 Years -	Pfizer
Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer	NCT00609622	Colorectal Neop...	sunitinib mFOLFOX6 bevacizumab mFOLFOX6	18 Years -	Pfizer
Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer	NCT00609622	Colorectal Neop...	sunitinib mFOLFOX6 bevacizumab mFOLFOX6	18 Years -	Pfizer

Spots Global Cancer Trial Database for metastatic colorectal cancer sunitinib (sutent) bevacizumab (avastin) randomized study