Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Disease Progression

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Oxaliplatin

Bevacizumab

Capecitabine

Erlotinib Hydrochloride

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

bevacizumab [Avastin]

eloxatin

capecitabine [Xeloda]

erlotinib [Tarceva]

Clinical Trials

This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.

An Open-label Study of the Effect of First-line Treatment With Avastin+Xelox, Followed by Avastin+Tarceva, on Progression-free Survival in Patients With Metastatic Colorectal Cancer

Disease progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.

Progression-free survival was defined as the time from the date of informed consent until the date when the participant had progression of disease or died from disease progression. Participants who received surgical treatment after treatment ended were censored at the time of surgery. Participants who left the study for reasons other than progression of the disease were censored on the date on which they received a later antitumor therapy (with the same or different drugs, radiotherapy, or surgery).

Percentage of participants with objective response based assessment of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than \[\<\]10 millimeters \[mm\]) and no new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

Percent of participants with confirmed CR, PR, or NC. Per RECIST version (v)1.0: CR was defined as disappearance of all target and non-target lesions. PR was defined as ≥30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. NC was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions.

Overall survival was defined as the time from the date of informed consent to the date of death (regardless of the cause of death). There was no restriction; survival was calculated until the date of death, even if another line of treatment was received, or until the date censored (last contact with the participant even if drugs different from the study treatment schedule were received). For all participants, survival information was collected until the date of death, the last contact, or the last follow-up.

Hoffmann-La Roche

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A separate analysis of nonserious AEs was not performed, therefore the AE section includes all AEs reported during the study, not just nonserious events.

A cycle was defined as the following: participants received 7.5 mg/kg bevacizumab, IV on Day 1; 130 mg/m\^2 eloxatin tablets, orally, on Days 1 through 14; and 1000 mg/m\^2 capecitabine tablets, orally, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. If all 6 cycles were tolerated with no disease progression, participants then received 7.5 mg/kg bevacizumab, IV on Day 1 and 150 mg erlotinib tablets, orally, once daily. This cycle was repeated every 3 weeks until disease progression.

Bevacizumab+Eloxatin+Capecitabine/Bevacizumab+Erlotinib

Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.

Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.

Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib

Age, Continuous

Sex: Female, Male

Intent-to-treat (ITT) population: all enrolled participants.

Medical Communications

Percentage of Participants With Disease Progression or Death

Response-Evaluable population: all enrolled participants who received at least 3 cycles of treatment, had all baseline lesions evaluated at least once after receiving the third cycle (using same technique as at baseline), and were without major violations of the study protocol.

Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])

Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC])

ACycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.

Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.

Percentage of Participants Who Died

Progression-Free Survival

Overall Survival (OS)

Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m\^2) IV on Day 1 and capecitabine 1000 mg/m\^2, tablet, orally (PO), every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.

Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.

Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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