Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Herbal and Botanical

Antibodies

Antibodies, Monoclonal

Bevacizumab

Irinotecan

Leucovorin

Fluorouracil

Oxaliplatin

Immunoglobulins

Endothelial Growth Factors

Mitogens

Panitumumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Cola

Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone.

Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W

Irinotecan-based chemotherapy and Bevacizumab Q2W alone

Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W

Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.

Oxaliplatin Based Chemotherapy

PanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab.

Irinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration.

Irinotecan Based Chemotherapy

Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .

The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.

PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study

PACCE: A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab With and Without Panitumumab in the First-Line Treatment of Subjects With Metastatic Colorectal Cancer

Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression

Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum

Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin

Best overall response of complete or partial response within oxaliplatin stratum

Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the oxaliplatin stratum

Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the oxaliplatin stratum.

Incidence of mortality from any cause in groups treated with Irinotecan. Incidence is provided in lieu of the median time to death since the median or its measure of dispersion was not estimable for at least one treatment arm.

Best overall response of complete or partial response within irinotecan stratum

Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the irinotecan stratum

Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the irinotecan stratum

Amgen

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Panit. Plus Bevacizumab With Chemotherapy

Bevacizumab With Chemotherapy

Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone

Oxaliplatin and Bevacizumab Without Panitumumab

Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W

Irinotecan and Bevacizumab Plus Panitumumab

Irinotecan and Bevacizumab Without Panitumumab

Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W

Oxaliplatin and Bevacizumab Plus Panitumumab

Total

Age, Continuous

Sex: Female, Male

White or Caucasian

Black or African American

Hispanic or Latino

Asian

Japanese

American Indian or Alaska Native

Native Hawaiian or Other Pacific Islander

Other

Race/Ethnicity, Customized

Eastern Cooperative Oncology Group (ECOG) Score

ECOG Score

None

Number of Metastatic Organs

Colon

Rectal

Primary Site of Disease

Prior adjuvant chemotherapy

Study Director

Progression-Free Survival (Oxaliplatin)

Overall Survival (Oxaliplatin)

Objective Tumor Response Rate (Oxaliplatin)

Time to Progression (Oxaliplatin)

Time to Treatment Failure (Oxaliplatin)

Objective Tumor Response Through Week 12 (Irinotecan)

Overall Survival (Irinotecan)

Progression-free Survival (Irinotecan)

Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS)

Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with oxaliplatin

Progression-free Survival (Wild-type KRAS)

Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS)

Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with oxaliplatin

Progression-free Survival (Mutant KRAS)

Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median

Overall Survival (Wild-type KRAS)

Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median.

Overall Survival (Mutant KRAS)

Best overall response of complete or partial response in participants treated with irinotecan and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS)

Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with irinotecan

Objective Tumor Response Rate (Wild-type KRAS)

Best overall response of complete or partial response in participants treated with irinotecan and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS)

Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with irinotecan

Spots Global Cancer Trial Database for irinotecan based chemotherapy