Pancreatic CancerPhase 2NCT00585078

Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

A Phase 2 study testing Capecitabine and Oxaliplatin in people with Pancreatic Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Cancer
What is being tested?: Capecitabine and Oxaliplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: May 2004to Dec 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115

Other trials in United States

About this study

Read the detailed description

OBJECTIVES:

Primary

To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma Secondary
To determine safety
To determine overall survival
To determine time to progression

Conditions: Pancreatic Cancer
Being tested: Capecitabine, Oxaliplatin
Keywords: capecitabine, oxaliplatin
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CapecitabineDrug
Also called Xeloda
OxaliplatinDrug
Also called Eloxatin

Study groups in NCT00585078
Study group	Role	What they receive
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. Receives: Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.
Measured: 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
Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.
Measured: 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
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from treatment or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2004Dec 2011

First posted3 Jan 2008 (estimated)
Study startMay 2004
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pancreatic CancerStudies of the same condition, open and under way.
More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00585078
Sponsor's protocol ID: 03-398
Other IDs: OX-03-033
Status last verified: Feb 2017
First submitted: 24 Dec 2007
Last updated: 10 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
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RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
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RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
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RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
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All Pancreatic Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma
ClinicalTrials.gov ID: NCT00585078
Acronym / sponsor ID: 03-398
Conditions: Pancreatic Cancer
Keywords: capecitabine, oxaliplatin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Collaborators: Sanofi
Study start: May 2004 (actual)
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 3 Jan 2008 (estimated)
Results: Posted 10 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Primary

To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma Secondary
To determine safety
To determine overall survival
To determine time to progression

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CAPOX	Experimental	Drug: Capecitabine, Drug: OxaliplatinParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

18 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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CapecitabineAlso: Xeloda	Drug	CAPOX
OxaliplatinAlso: Eloxatin	Drug	CAPOX

Primary outcome

Response Rate
Time frame: 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.
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.

3 secondary outcomes

Best Response
Time frame: 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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 10 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CAPOX	40	0

Primary outcome: Response Rate

Time frame: 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.. Number (80% Confidence Interval). Unit: proportion of participants

Measure	CAPOX n = 24
Value	.125 (.035 to .201)

Population analysed: The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Assessed each cycle on day 1 and mid-cycle (between days 10 and 14) from time of first dose and up to day 30 post-treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CAPOX	18 of 36 (50%)	34 of 36 (94.4%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Pancreatic Cancer

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rebecca Miksad, MD, MPH principal investigator

Beth Israel Deaconess Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine and Oxaliplatin in people with Pancreatic Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00585078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.