Pancreatic CancerPhase 2NCT01459614
Gemcitabine/Taxotere/Xeloda (GTX) With Cisplatin in Subjects With Metastatic Pancreatic Cancer
A Phase 2 study testing Gemcitabine, Taxotere and Xeloda in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
Primary Objectives To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with cisplatin in subjects with metastatic pancreatic cancer based on the progression-free survival (PFS) rate at 6 month. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine, Taxotere and Xeloda
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Nov 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma. Subjects with islet cell neoplasms are excluded. Subjects with mixed histology will be excluded.
- Subject has one or more tumors measurable by CT scan using RECIST 1.1 criteria. MRI is acceptable if a CT scan is contraindicated.
- Patient must be chemotherapy naïve or must have completed chemotherapy greater than 5 years prior to enrollment.
- Male or non-pregnant and non-lactating female of age >18 years
- ECOG performance status <1. ECOG 0 indicates that the patient is fully active and able to carry on all pre-disease activities without restriction; and, ECOG 1 indicates that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature
- Life expectancy of greater than 12 weeks.
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- Subjects must have adequate organ and marrow function as defined below:
- WBC ≥ 3,500/mcL Absolute Neutrophil Count ≥1,500/mcL Platelets ≥100 x 10^9/L Hemoglobin ≥ 9 g/d Total Bilirubin within normal institutional limits Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 X ULN for subjects with documented liver metastases) AST(SGOT)/ALT(SGPT) ≤ 2.5 x ULN (≤ 5 X ULN for subjects with documented liver metastases) Creatinine within normal institutional limits OR Creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Willingness to undergo a tumor biopsy (implemented after the first 6 patients).
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects who have had any prior chemotherapy within 5 years of enrollment
- Subjects who have had radiotherapy for pancreatic cancer.
- Age ≥ 76 years
- Subjects who are receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
- Subject has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis or an aborted Whipple), within 28 days prior to Day 1 of treatment in this study.
- Subject has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids).
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- History of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, taxotere, xeloda, or cisplatin.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subject has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the subject to receive an experimental research drug.
- Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Subject has a known history of infection with HIV, hepatitis B, or hepatitis C.
- Subject is pregnant or breast feeding.
- Subject is unwilling or unable to comply with study procedures.
- Subject with an unhealed surgical wound or other clinically significant wound.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21205
About this study
Official title: Phase II Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin in Subjects With Metastatic Pancreatic Cancer
Primary Objectives
To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with cisplatin in subjects with metastatic pancreatic cancer based on the progression-free survival (PFS) rate at 6 month.
Read more
Secondary Objectives
- To assess safety and characterize toxicities of the combination of GTX with cisplatin in subjects with metastatic pancreatic cancer.
- To estimate disease control rate (DCR), PFS, and overall survival (OS).
- To estimate a PFS rate of an expansion cohort testing an alternative schedule.
Study Design
This study is a single arm phase II study to assess the efficacy of GTX with cisplatin in subjects with metastatic pancreatic cancer. Approximately 38 evaluable subjects will be enrolled, 28 in the initial cohort and 10 in the expansion cohort
The study will have a safety run-in phase consisting of 6 subjects. To ensure that the combination is safe, the first six subjects will be treated at DL1 and observed for limiting toxicity for the first 2 cycles before continuation with further accrual. After the safety run-in, the study will be continuously monitored for adverse events.
The primary endpoint will be the PFS rate at 6 month, which is defined as the proportion of subjects alive, free of disease progression at 6 months. The treatment regimen would be considered of insufficient activity for further study in this population if PFS rate at 6 months is 50% or less, and the minimum required level of efficacy that would warrant further study with the proposed regimen is a 75% PFS rate at 6 months. The study design includes interim monitoring for futility using a predictive probability approach. We will stop the study early if given the information at the interim analysis, it is unlikely that the PFS rate at 6 months will be greater than 50% if the study continues to the end.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, Taxotere, Xeloda, Cisplatin
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
IV on Days 4 and 11
TaxotereDrug
Also called Docetaxel
IV on Days 4 and 11
XelodaDrug
Also called Capecitabine
orally, twice a day Days 1-14
CisplatinDrug
Also called Platinol, CDDP
IV Days 4 and 11
| Study group | Role | What they receive |
|---|---|---|
| GTX-C | Experimental | Each cycle is 21 days (2 weeks Tx + 1 week off). Xeloda given days 1-14, Gemcitabine, Taxotere, and Cisplatin given days 4 and 11.
For expansion cohort, each cycle is 28 days (2 weeks of Tx + 2 weeks off) Receives: Drug: Gemcitabine; Drug: Taxotere; Drug: Xeloda; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Without Disease Progression (Progression-Free Survival) at 6 Months
PFS is defined as the percentage of patients with disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause at 6 months. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Measured: 6 months
Secondary outcomes (4)
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject. AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months.
Measured: Up to 23 months
Disease Control Rate (DCR)
DCR is defined as the percentage of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
Measured: Up to 22 months
Progression-free Survival (PFS)
PFS is defined as the the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause . Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Measured: Up to 21 months
Overall Survival (OS)
OS (in months) will be measured from date of first dose until death (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Measured: Up to 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2016
- Study completionNov 2016
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 Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Swim Across America
- Responsible party
- Sponsor
- Investigators
- Dung Le, MD, Principal investigator, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459614
- Sponsor's protocol ID
- J11125
- Other IDs
- NA_00066595, Swim Across America Laboratory
- Status last verified
- Apr 2021
- First submitted
- 24 Oct 2011
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wilbur HC, Durham JN, Lim SJ, Purtell K, Bever KM, Laheru DA, De Jesus-Acosta A, Azad NS, Wilt B, Diaz LA, Le DT, Wang H. Gemcitabine, Docetaxel, Capecitabine, Cisplatin, Irinotecan as First-line Treatment for Metastatic Pancreatic Cancer. Cancer Res Commun. 2023 Aug 28;3(8):1672-1677. doi: 10.1158/2767-9764.CRC-23-0230. eCollection 2023 Aug.
PubMed 37645623
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin in Subjects With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01459614
- Acronym / sponsor ID
- J11125
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Swim Across America
- Study start
- Nov 2011 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives
To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with cisplatin in subjects with metastatic pancreatic cancer based on the progression-free survival (PFS) rate at 6 month.
Secondary Objectives
- To assess safety and characterize toxicities of the combination of GTX with cisplatin in subjects with metastatic pancreatic cancer.
- To estimate disease control rate (DCR), PFS, and overall survival (OS).
- To estimate a PFS rate of an expansion cohort testing an alternative schedule.
Study Design
This study is a single arm phase II study to assess the efficacy of GTX with cisplatin in subjects with metastatic pancreatic cancer. Approximately 38 evaluable subjects will be enrolled, 28 in the initial cohort and 10 in the expansion cohort
The study will have a safety run-in phase consisting of 6 subjects. To ensure that the combination is safe, the first six subjects will be treated at DL1 and observed for limiting toxicity for the first 2 cycles before continuation with further accrual. After the safety run-in, the study will be continuously monitored for adverse events.
The primary endpoint will be the PFS rate at 6 month, which is defined as the proportion of subjects alive, free of disease progression at 6 months. The treatment regimen would be considered of insufficient activity for further study in this population if PFS rate at 6 months is 50% or less, and the minimum required level of efficacy that would warrant further study with the proposed regimen is a 75% PFS rate at 6 months. The study design includes interim monitoring for futility using a predictive probability approach. We will stop the study early if given the information at the interim analysis, it is unlikely that the PFS rate at 6 months will be greater than 50% if the study continues to the end.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GTX-C | Experimental | Drug: Gemcitabine, Drug: Taxotere, Drug: Xeloda, Drug: CisplatinEach cycle is 21 days (2 weeks Tx + 1 week off). Xeloda given days 1-14, Gemcitabine, Taxotere, and Cisplatin given days 4 and 11. For expansion cohort, each cycle is 28 days (2 weeks of Tx + 2 weeks off) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma. Subjects with islet cell neoplasms are excluded. Subjects with mixed histology will be excluded.
- Subject has one or more tumors measurable by CT scan using RECIST 1.1 criteria. MRI is acceptable if a CT scan is contraindicated.
- Patient must be chemotherapy naïve or must have completed chemotherapy greater than 5 years prior to enrollment.
- Male or non-pregnant and non-lactating female of age >18 years
- ECOG performance status <1. ECOG 0 indicates that the patient is fully active and able to carry on all pre-disease activities without restriction; and, ECOG 1 indicates that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature
Key exclusion criteria (14 listed)
- Subjects who have had any prior chemotherapy within 5 years of enrollment
- Subjects who have had radiotherapy for pancreatic cancer.
- Age ≥ 76 years
- Subjects who are receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
- Subject has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis or an aborted Whipple), within 28 days prior to Day 1 of treatment in this study.
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 |
|---|---|---|
| GemcitabineIV on Days 4 and 11 | Drug | GTX-C |
| TaxotereAlso: DocetaxelIV on Days 4 and 11 | Drug | GTX-C |
| XelodaAlso: Capecitabineorally, twice a day Days 1-14 | Drug | GTX-C |
| CisplatinAlso: Platinol, CDDPIV Days 4 and 11 | Drug | GTX-C |
Primary outcome
Percentage of Participants Without Disease Progression (Progression-Free Survival) at 6 Months
Time frame: 6 months
PFS is defined as the percentage of patients with disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause at 6 months. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
4 secondary outcomes
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
Time frame: Up to 23 months
Disease Control Rate (DCR)
Time frame: Up to 22 months
Progression-free Survival (PFS)
Time frame: Up to 21 months
Overall Survival (OS)
Time frame: Up to 28 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37645623Wilbur HC, Durham JN, Lim SJ, Purtell K, Bever KM, Laheru DA, De Jesus-Acosta A, Azad NS, Wilt B, Diaz LA, Le DT, Wang H. Gemcitabine, Docetaxel, Capecitabine, Cisplatin, Irinotecan as First-line Treatment for Metastatic Pancreatic Cancer. Cancer Res Commun. 2023 Aug 28;3(8):1672-1677. doi: 10.1158/2767-9764.CRC-23-0230. eCollection 2023 Aug.
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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.
Dung Le, MD principal investigator
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 Gemcitabine, Taxotere and Xeloda in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 11 inclusion and 14 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 19 May 2021. 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 23 Jan 2019). 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?
Percentage of Participants Without Disease Progression (Progression-Free Survival) at 6 Months (time frame: 6 months). 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 NCT01459614, 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 19 May 2021.