Pancreatic CancerPhase 2NCT00290693
Capecitabine and Docetaxel in Treating Patients With Recurrent or Progressive Metastatic Pancreatic Cancer
A Phase 2 study testing Capecitabine and Docetaxel in people with Pancreatic Cancer, run by University of Miami at 3 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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 Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2004to Jun 2010
- 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
- Participants or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
- Patients must be 18 years or older.
- Participants must have recurrence or progression of histologically or cytologically documented pancreatic adenocarcinoma. Re-documentation of tumor histology or cytology prior to protocol therapy is not required if documented tumor was confirmed prior to initial therapy.
- Patients must have metastatic disease.
- Patients with metastatic disease to the brain if they have received radiation therapy or are stable, and are not receiving steroids or anticonvulsants.
- Participants must have received one prior gemcitabine based chemotherapy regimen (with or without radiation therapy). Participants must be 3 weeks or more beyond completion of prior chemotherapy (30 days beyond any experimental agent) and show recovery from toxicity to within the eligibility parameters of this protocol.
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- Radiation for palliation and of the primary tumor must have been completed at least four weeks prior to initiation of protocol therapy.
- Patients must have measurable tumor by Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al, 2000). Measurable disease includes any lesion ≥ 1 cm by spiral CT or ≥ 2 cm by non-spiral CT in longest diameter which can be repetitively assessed by radiographic measurement or any lesion ≥ 2 cm in longest diameter which can be repetitively assessed by physical examination. Positive bone scans, osteoblastic or osteolytic bone lesions, pleural effusions and positive bone marrow biopsies are not considered acceptable as either measurable or evaluable lesions.
- Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0,1, or 2.
- Females of reproductive potential must not plan on conceiving children during the treatment period and must agree to use an effective medically accepted form of contraception. Patients will agree to continue contraception for 60 days from the date of the last study drug administration.
- Required initial laboratory data:
- Granulocytes ≥ 1,500/µl
- Platelets ≥ 100,000/µl
- Hg ≥ 8.0 g/dL
- Creatinine ≤ 2.0 mg/dL
- Creatine Clearance >30 ml/min as calculated with Cockroft-Gault equation
- Bilirubin ≤ Upper Limits of Normal (ULN)
- Pregnancy test for females with child-bearing potential: Negative within 7 days of starting protocol
- Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is ≤ ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are ≤ ULN.
Who cannot join
- Patient currently enrolled in another clinical trial.
- Pregnant or breast feeding women. With the exception of post-menopausal or infertile women, a negative blood test for pregnancy is mandatory before entry on study. Fertile persons refusing to use contraceptives may not participate.
- Participants may not have had capecitabine or docetaxel as part of prior therapy.
- No concurrent clinically evident malignancy is allowed except inactive non-melanoma skin cancer, low grade low stage bladder carcinoma followed off therapy, treated in-situ cervical cancer or lobular neoplasia of the breast.
- Participants with serious uncontrolled medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
- Pregnant or breast-feeding at the time of proposed study entry.
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- Clinical AIDS or known positive HIV serology.
- Peripheral neuropathy > grade 1
- Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 must be excluded.
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Major Surgery within 4 weeks of the start of study treatment, without complete recovery.
- Unwillingness to participate or inability to comply with the protocol for the duration of the study.
- Patients with impaired renal function (estimated creatinine clearance < 30 ml/min as calculated by the Cockroft-Gault Equation).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
University of Miami
Miami, Florida, 33136
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center
Miami Beach, Florida, 33140
About this study
Official title: A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients "CapTere"
RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel works in treating patients with recurrent or progressive metastatic pancreatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the overall (complete and partial) response rate in patients with recurrent or progressive metastatic pancreatic cancer treated with capecitabine and docetaxel.
Secondary
- Determine the overall and progression-free survival of patients treated with the chemotherapy combination.
- Determine the duration of response (complete or partial) among patients who attain a response.
- Determine the frequency of patients having > 50% fall of CA19-9 from an initial level of > 100 U/mL in association with treatment with this regimen.
- Evaluate the toxicity associated with the administration of the combination in these patients.
OUTLINE: This is a multicenter, open-label, nonrandomized study.
Patients receive oral capecitabine twice daily on days 1-14 and docetaxel IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 1 year.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
- Conditions
- Pancreatic Cancer
- Being tested
- Capecitabine, Docetaxel
- Keywords
- recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- 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
Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle
DocetaxelDrug
Also called Taxotere
30 mg/m2, IV, days 1 and 8 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| CapTere (Capecitabine + Docetaxel) | Experimental | Capecitabine + Docetaxel (Taxotere) Receives: Drug: Capecitabine; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Participants Achieving Complete Response or Partial Response to Therapy.
Rate of participants achieving complete response (CR) or partial response (PR) to Captere therapy according to RECIST criteria v 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Measured: Up to 1 year
Secondary outcomes (4)
Overall Surival (OS)
Overall survival is measured from the time from date of initial protocol therapy to date of death. In the absence of confirmation of death, survival time will be censored to last date of follow-up.
Measured: Up to 1 year
Progression-free Survival (PFS)
Progression-free survival (PFS) is measured the time from the start of protocol therapy to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 1 year
Rate of Participants Achieving a 50% or More Reduction in CA 19-9 Levels
Rate of participants achieving a 50% or more reduction in CA 19-9 levels after receiving protocol therapy. Baseline CA-19-9 will be compared to the lowest recorded value on patients receiving therapy on protocol. A 50% drop in CA 19-9 in patients with baseline levels above 100 U/ml will be recorded as a CA 19-9 response if the > 50% drop can be confirmed with at least one more CA 19-9 level thereafter with > 50% drop compared to baseline.
Measured: Up to 1 year
Number of Study Participants Experiencing Toxicity After Receiving Protocol Therapy
Number of study participants experiencing toxicity (serious adverse events or adverse events). Study participants assessed for this outcome measure must have received at least one dose of protocol therapy. Toxicity assessed according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startJul 2004
- Primary completionAug 2008
- Study completionJun 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caio Max S. Rocha Lima, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290693
- Sponsor's protocol ID
- 20030652
- Other IDs
- SCCC-2003099, WIRB-20051007, AVENTIS-14056
- Status last verified
- Oct 2017
- First submitted
- 9 Feb 2006
- Last updated
- 2 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Soares HP, Bayraktar S, Blaya M, Lopes G, Merchan J, Macintyre J, Mayo C, Green MR, Silva O, Levi J, Walker G, Rocha-Lima CM. A phase II study of capecitabine plus docetaxel in gemcitabine-pretreated metastatic pancreatic cancer patients: CapTere. Cancer Chemother Pharmacol. 2014 Apr;73(4):839-45. doi: 10.1007/s00280-014-2414-z. Epub 2014 Feb 23.
PubMed 24562589
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients "CapTere"
- ClinicalTrials.gov ID
- NCT00290693
- Acronym / sponsor ID
- 20030652
- Conditions
- Pancreatic Cancer
- Keywords
- recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jul 2004 (actual)
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Feb 2006 (estimated)
- Results
- Posted 13 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel works in treating patients with recurrent or progressive metastatic pancreatic cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the overall (complete and partial) response rate in patients with recurrent or progressive metastatic pancreatic cancer treated with capecitabine and docetaxel.
Secondary
- Determine the overall and progression-free survival of patients treated with the chemotherapy combination.
- Determine the duration of response (complete or partial) among patients who attain a response.
- Determine the frequency of patients having > 50% fall of CA19-9 from an initial level of > 100 U/mL in association with treatment with this regimen.
- Evaluate the toxicity associated with the administration of the combination in these patients.
OUTLINE: This is a multicenter, open-label, nonrandomized study.
Patients receive oral capecitabine twice daily on days 1-14 and docetaxel IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 1 year.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CapTere (Capecitabine + Docetaxel) | Experimental | Drug: Capecitabine, Drug: DocetaxelCapecitabine + Docetaxel (Taxotere) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Participants or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
- Patients must be 18 years or older.
- Participants must have recurrence or progression of histologically or cytologically documented pancreatic adenocarcinoma. Re-documentation of tumor histology or cytology prior to protocol therapy is not required if documented tumor was confirmed prior to initial therapy.
- Patients must have metastatic disease.
- Patients with metastatic disease to the brain if they have received radiation therapy or are stable, and are not receiving steroids or anticonvulsants.
Key exclusion criteria (15 listed)
- Patient currently enrolled in another clinical trial.
- Pregnant or breast feeding women. With the exception of post-menopausal or infertile women, a negative blood test for pregnancy is mandatory before entry on study. Fertile persons refusing to use contraceptives may not participate.
- Participants may not have had capecitabine or docetaxel as part of prior therapy.
- No concurrent clinically evident malignancy is allowed except inactive non-melanoma skin cancer, low grade low stage bladder carcinoma followed off therapy, treated in-situ cervical cancer or lobular neoplasia of the breast.
- Participants with serious uncontrolled medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
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: XelodaOrally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle | Drug | CapTere (Capecitabine + Docetaxel) |
| DocetaxelAlso: Taxotere30 mg/m2, IV, days 1 and 8 every 3 weeks | Drug | CapTere (Capecitabine + Docetaxel) |
Primary outcome
Rate of Participants Achieving Complete Response or Partial Response to Therapy.
Time frame: Up to 1 year
Rate of participants achieving complete response (CR) or partial response (PR) to Captere therapy according to RECIST criteria v 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
4 secondary outcomes
Overall Surival (OS)
Time frame: Up to 1 year
Progression-free Survival (PFS)
Time frame: Up to 1 year
Rate of Participants Achieving a 50% or More Reduction in CA 19-9 Levels
Time frame: Up to 1 year
Number of Study Participants Experiencing Toxicity After Receiving Protocol Therapy
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24562589Soares HP, Bayraktar S, Blaya M, Lopes G, Merchan J, Macintyre J, Mayo C, Green MR, Silva O, Levi J, Walker G, Rocha-Lima CM. A phase II study of capecitabine plus docetaxel in gemcitabine-pretreated metastatic pancreatic cancer patients: CapTere. Cancer Chemother Pharmacol. 2014 Apr;73(4):839-45. doi: 10.1007/s00280-014-2414-z. Epub 2014 Feb 23.
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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.
Caio Max S. Rocha Lima, MD principal investigator
University of Miami
3 sites 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 Docetaxel in people with Pancreatic Cancer, run by University of Miami at 3 sites 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 19 inclusion and 15 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 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 13 May 2013). 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?
Rate of Participants Achieving Complete Response or Partial Response to Therapy. (time frame: Up to 1 year). 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 NCT00290693, which also lists 1 linked publication.
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 2 Dec 2017.