Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Bevacizumab

Leucovorin

Fluorouracil

Capecitabine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

5 mg/kg intravenously every 2 weeks, 4 cycles

bevacizumab [Avastin]

capecitabine [Xeloda]

Radiation therapy

6-8 weeks after completion of neoadjuvant treatment

Mesorectal excision

Post-surgery adjuvant treatment at the discretion of the investigator: 5 mg/kg iv every 2 weeks for at least 6 months

Post-surgery adjuvant therapy: bolus of 400mg/m2 iv plus iv infusion of 600 mg/m2 on Days 1 and 2 of each 2-week cycle for 6 months

5-fluorouracil

Post-surgery adjuvant treatment: 100 mg/m2 iv on Days 1 and 2 of each 2-week cycle for 6 months

leucovorin

Clinical Trials

This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer. Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2 weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy. After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.

A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.

An Open-label Study to Assess the Effect of Combination Treatment With Avastin and Xeloda, Plus Pre-operative Standard Radiotherapy, on Response Rate in Patients With Locally Advanced Rectal Cancer.

pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.

The frequencies of clinical tumor stage T (0, 1, 2, 3, 4, or X), regional lymph nodes stage N (0, 1, 2, 3, or 4), and distant metastasis clinical stage M (0, 1, or X) at baseline and at the end of NAT were assessed. The frequencies of pathological tumor stage T and regional lymph nodes stage N at surgery were evaluated. The clinical tumor and lymph node status was assessed by clinical examination, endosonography, and/or rectosigmoidoscopy, and pelvic and abdomen computerized tomography (CT) scan or magnetic resonance imaging (MRI). Response to treatment had to be assessed within 6 weeks after end of treatment by using the same techniques performed at baseline.

Percentage of participants with CR was evaluated as the proportion of participants with complete response for the target and non-target lesions, separately, at the end of NAT according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions or all non-target lesions and normalization of tumor marker levels.

Percentage of participants with an overall response of CR was evaluated as the proportion of participants with CR for the target and non-target lesions plus absence of new lesions at the end of NAT according to RECIST. CR was defined as disappearance of all target lesions, all non-target lesions, and normalization of tumor marker levels.

The percentage of participants with new lesions located at the primary tumor site were evaluated at the end of NAT.

The percentage of participants with local and/or regional relapse during follow-up. New lesions located at rectum or at colon or at lymph node detected at the end of NAT were evaluated as local and/or regional relapse.

DFS was defined as the time from treatment start date to the date of first progression of disease or date of death due to any cause.

The time in months from date of start-of-treatment to the date of event defined as the first documented disease progression or death due to any cause. If a participant did not have an event, the time was censored at the date of last adequate tumor assessment. DFS was estimated using the Kaplan-Meier method.

OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive.

OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. OS was estimated using the Kaplan-Meier method.

TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer.

TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. TTP was estimated using the Kaplan-Meier method.

Hoffmann-La Roche

All enrolled participants who received at least 1 dose of study medication were included in the safety population.

Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.

Bv+Capecitabine/Bv+Leucovorin+5-FU

Age, Continuous

Sex: Female, Male

Intent to treat (ITT) population: all participants who were included in the trial by signing the informed consent and were assigned to a study patient number.

Medical Communications

ITT population; only participants who underwent surgery and had pathological tumor stage data were included in the analysis.

Percentage of Participants With Pathological Complete Response (pCR)

Baseline: T0, N0

End of NAT: T0, N0

Baseline: T1, N0

End of NAT: T1, N0

Baseline: T1, NX

End of NAT: T1, NX

Baseline: T2, N0

End of NAT: T2, N0

Baseline: T2, N1

End of NAT: T2, N1

Baseline: T2, NX

End of NAT: T2, NX

Baseline: T3, N0

End of NAT: T3, N0

Baseline: T3, N1

End of NAT: T3, N1

Baseline: T3, N2

End of NAT: T3, N2

Baseline: T3, NX

End of NAT: T3, NX

Baseline: T4, N0

End of NAT: T4, N0

Baseline: T4, N1

End of NAT: T4, N1

Baseline: T4, N2

End of NAT: T4, N2

Baseline: T4, N3

End of NAT: T4, N3

Baseline: TX, N0

End of NAT: TX, N0

Baseline: TX, N2

End of NAT: TX, N2

Baseline: M0

End of NAT: M0

Baseline: M1

End of NAT: M1

Baseline: MX

End of NAT: MX

Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)

Anterior resection

Abdomen-peritoneal amputation (Miles)

Other

Colostomy, temporary (n=32)

Colostomy, definitive (n=32)

No colostomy

ITT population; only participants who underwent surgery were included in the analysis. n (number) equals (=) number of participants assessed for the specified parameter (colostomy)

Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure

CR of target lesion(s)

CR of non-target lesion(s)

Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment

Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment

Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment

No Relapse

1 Relapse

2 Relapses

ITT population; only participants who underwent radical surgery were included in the analysis

Percentage of Participants With Relapse During Follow-Up

Disease-Free Survival (DFS) - Percentage of Participants With an Event

DFS - Time to Event

Overall Survival (OS) - Percentage of Participants With an Event

OS - Time to Event

Time to Disease Progression (TTP) - Percentage of Participants With an Event

TTP - Time to Event

Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days -14, 1, 15, and 29 and capecitabine 825 milligrams per square meter (mg/m\^2) orally (PO) twice daily (BID) from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gray (Gy) administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-fluorouracil (5-FU) 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.

Bevacizumab (Bv)+Capecitabine/Bv+Leucovorin+5-fluorouracil

Overall Study

Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial