Phase 1 N=30 Treatment

ATX Study:A Study of Avastin (Bevacizumab), Tarceva (Erlotinib) and Xeloda (Capecitabine) in Patients With Locally Advanced and/or Metastatic Pancreatic Cancer

Pancreatic Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00925769 ↗

Enrolled (actual)

Serious AEs

66.7%

Results posted

Aug 2015

Primary outcome: Primary: Part 1: Maximum Tolerated Dose (MTD) of Capecitabine — 900 mg/m^2 BID

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: bevacizumab [Avastin] (Drug); capecitabine [Xeloda] (Drug); erlotinib [Tarceva] (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Part 1: Maximum Tolerated Dose (MTD) of Capecitabine	900	—
PRIMARY Part 1: MTD of Erlotinib	NA	—
PRIMARY Part 1: MTD of Bevacizumab	NA	—
PRIMARY Part 1: Preliminary Recommended Dose (PRD) of Capecitabine for Part 2	800	—
PRIMARY Part 1: PRD of Erlotinib for Part 2	150	—
PRIMARY Part 1: PRD of Bevacizumab for Part 2	10	—
SECONDARY Part 1: Maximum Serum Concentration (Cmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR] and 5'-Deoxy-5-Fluorouridine [5'-DFUR])	1.50; 0.95; 0.68; 0.93; 0.58; 1.69	—
SECONDARY Part 1: Time to Reach Cmax (Tmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)	2.50; 2.00; 2.00; 3.00; 5.00; 2.00	—
SECONDARY Part 1: Last Quantifiable Drug Concentration (Clast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)	0.37; 0.31; 0.23; 0.39; 0.23; 0.52	—
SECONDARY Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)	15.81; 11.06; 9.15; 13.07; 8.54; 19.88	—
SECONDARY Part 2: Percentage of Participants Free From Disease Progression	—	—
SECONDARY Part 2: Percentage of Participants With Disease Control	—	—
SECONDARY Part 2: Percentage of Participants With Clinical Benefit Response	—	—
SECONDARY Part 2: Overall Survival	—	—

Summary

This 2 part study will evaluate the safety and efficacy of a combination of Avastin, Tarceva and Xeloda (ATX) as second-line treatment in patients with locally advanced and/or metastatic pancreatic cancer. In the first part of the study, cohorts of patients will receive escalating doses of combination treatment to determine the maximum tolerated dose. The recommended dose will be used in the second part of the study to determine the efficacy of the ATX regime, in terms of its effect on disease progression. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Eligibility Criteria

Inclusion Criteria

adult patients, >=18 years of age;
pancreatic cancer with locally advanced and/or metastatic disease (stage IV);
chemonaive for metastatic or locally advanced disease;
ECOG performance status of 0-2.

Exclusion Criteria

local (stage IA to IIB)and locally advanced (stage III) pancreatic cancer;
previous exposure to Avastin, Tarceva or Xeloda;
other primary tumor within the last 5 years prior to enrollment, except for adequately treated cancer in situ of cervix, or basal cell skin cancer;
current or recent chronic use of aspirin (>325 mg/day) or full therapeutic dose of anticoagulants or thrombolytic agents.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00925769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.