Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

NCT00585078 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 03-398OX-03-033
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

There are limited treatment options available for patients with advanced pancreatic ductal adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced and metastatic PDAC treated in the first and second lines.

Conditions

Pancreatic Cancer

Keywords

capecitabine; oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Response rate (RR) is defined as the proportion of participants achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

  Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.

Secondary Outcomes (3)

• Best Response

  Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.

• Overall Survival

  Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median survival follow-up was 10.8 months (95% CI: 7.1-37.7) in this study cohort.

• Progression-Free Survival

  Disease evaluations occurred every two cycles (42 days ±2 days) on treatment. In this study cohort, participants were followed for progression up to 38 months.

Study Arms (1)

CAPOX

EXPERIMENTAL

Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.

Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Capecitabine DRUG

Also known as: Xeloda

CAPOX

Oxaliplatin DRUG

Also known as: Eloxatin

CAPOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• At most one prior chemotherapy regimen for unresectable or metastatic disease. Any adjuvant chemotherapy must have been completed more than 12 months prior to beginning protocol therapy
• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• At least one measurable lesion according to RECIST criteria that has not been irradiated
• Adequate laboratory parameters as outlined in protocol
• Anticoagulation with coumadin is permitted, but PT/INR must be monitored closely, given the drug-drug interaction between coumadin and capecitabine
• Negative serum pregnancy test within 14 days prior to registration

You may not qualify if:

• Pregnant or lactating women
• Life expectancy \< 3 months
• Serious, uncontrolled, concurrent infection(s)
• Any prior oxaliplatin or fluoropyrimidine therapy
• More than one prior chemotherapy regimen for unresectable or metastatic disease
• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or platinum compounds
• Any active second malignancy
• Clinically significant cardiac disease or myocardial infarction within the last 12 months
• Evidence of CNS metastases or history of uncontrolled seizures, central nervous system disorders or psychiatric disability
• Other serious uncontrolled medical conditions
• Major surgery within 4 weeks of the start of study treatment, without complete recovery
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
• Known, existing uncontrolled coagulopathy

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Sanofi: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Rebecca Miksad MD MPH
• Organization: Beth Israel Deaconess Medical Center Beth Israel Deaconess

rmiksad@bidmc.harvard.edu

617.667.2100

Study Officials

• Rebecca Miksad, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Harvard University; Attending Physician, Beth Israel Deaconess Medical Center

Study Record Dates

• First Submitted: December 24, 2007
• First Posted: January 3, 2008
• Study Start: May 1, 2004
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 10, 2017
• Results First Posted: April 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)