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

Capecitabine

Oxaliplatin

Bevacizumab

Antimetabolites

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Avastin

capecitabine [Xeloda]

Clinical Trials

This single arm study will investigate possible pharmacokinetic interactions between Xeloda and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

A Study of Xeloda (Capecitabine) in Combination With Oxaliplatin in Patients With Metastatic Colorectal Cancer.

An Open-label Study to Assess the Pharmacokinetic Interaction Between Xeloda and Oxaliplatin in Patients With Metastatic Colorectal Cancer.

AUC0-infinity represents the area under the concentration-time curve of the analyte (5'-DFUR) in plasma over the time interval from 0 extrapolated to infinity. The analyte 5'-DFUR, the direct precursor of 5-fluorouracil (5-FU), is considered to be the most important metabolite of capecitabine in plasma. The unit of measure was nanograms per millilitre per hour (ng/mL \* hr).

AUC0-infinity represents the area under the concentration-time curve of the analyte (free platinum) in plasma over the time interval from 0 extrapolated to infinity. AUC0-inf for free platinum was calculated for each participant from the concentration-data obtained on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. Free platinum is not bound to plasma proteins and is considered to be the most clinically significant measure of pharmacological and toxicological activity.

AUC0-infinity represents the area under the concentration-time curve of the analytes (5'-DFCR, 5-FU, and FBAL) in plasma over the time interval from 0 extrapolated to infinity. After oral administration, capecitabine is first metabolized in the liver to 5'-deoxy-5-fluorocytidine (5'-DFCR), which is then converted to 5'-DFUR, and then catalytically activated to 5-FU.

Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of capecitabine and its metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL).

Cmax is defined as maximum observed analyte concentration of capecitabine and its metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL)

t1/2 Beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of capecitabine and its metabolites (5'-DFUR , 5'-DFCR, 5 FU, and FBAL)

AUC0-infinity represents the area under the concentration-time curve of the analyte (total platinum) in plasma over the time interval from 0 extrapolated to infinity.

Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of Total And Free Platinum.

Cmax is defined as maximum observed analyte concentration of Total And Free Platinum.

T1/2 beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of total and free platinum.

VSS is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

CL is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (hour).

An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. This includes any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during the study were also to be reported as AEs.

Number of participants with marked laboratory abnormalities (hematology, coagulation, liver function, renal function, protein, electrolytes, miscellaneous).

Hoffmann-La Roche

Adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m\^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m\^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m\^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m\^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m\^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m\^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m\^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent

Capecitabine+ Oxaliplatin+ Bevacizumab

Age, Continuous

Sex: Female, Male

Roche Trial Information Hotline

Cycle 1, Day 1

Cycle 2, Day 1

Cycle 3, Day 1

All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.

Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0-Inf) of 5'-Deoxy-5-fluorouridine 5'-(DFUR)

Cycle 1, Day 2

Cycle 2 , Day 1

Cycle 3, Day 1.

AUC0-inf for Free Platinum

Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1

Capecitabine: Cycle 3, Day 1 to Cycle 2, Day 1

Capecitabine: Cycle 3, Day 1 to Cycle 1, Day 1

5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1

5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1

5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1

5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1

5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1

5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1

FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1

FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1

FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1

Capcetabine , Cycle 1, Day 1

Capcetabine , Cycle 2, Day 1

Capcetabine , Cycle 3, Day 1

5'-DFCR , Cycle 1, Day 1

5'-DFCR , Cycle 2, Day 1

5'-DFCR, Cylce 3, Day 1

5-FU , Cycle 1, Day 1

5-FU , Cycle 2, Day 1

5-FU , Cycle 3, Day 1

FBAL , Cycle 1, Day 1

FBAL , Cycle 2, Day 1

FBAL , Cycle 3, Day 1

AUC (0-infinity) of Capecitabine and Its Metabolites (5'-DFCR, 5-FU, and FBAL)

5' DFUR , Cycle 1, Day 1

5' DFUR, Cycle 2 , Day 1

5' DFUR, Cycle 3, Day 1

Capecitabine, Cycle 1, Day 1

Capecitabine, Cycle 2, Day 1

Capecitabine, Cycle 3, Day 1

5'-DFCR, Cycle 1, Day 1

5'-DFCR, Cycle 2 , Day 1

5'-DFCR, Cycle 3, Day 1

5-FU, Cycle 1, Day 1

5-FU, Cycle 2, Day 1

5-FU, Cycle 3, Day 1

FBAL, Cycle 1, Day 1

FBAL, Cycle 2, Day 1

FBAL, Cycle 3, Day 1

AUC0-last of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL)

5'-DFUR: Cycle 2, Day 1 versus Cycle 1, Day 1

5'-DFUR: Cycle 3, Day 1 versus Cycle 1, Day 1

5'-DFUR: Cycle 3, Day 1 versus Cycle 2, Day 1

Capecitabine: Cycle 3, Day 1 versus Cycle 2, Day 1

Capecitabine: Cycle 3, Day 1 versus Cycle 1, Day 1

Spots Global Cancer Trial Database for A Study of Xeloda (Capecitabine) in Combination With Oxaliplatin in Patients With Metastatic Colorectal Cancer.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial