Metastatic Pancreatic CarcinomaPhase 1NCT00480584
A Phase I Trial of Capecitabine in Combination With Gemcitabine and Erlotinib for Advanced Pancreatic Cancer
A Phase 1 study testing gemcitabine, capecitabine and erlotinib in people with Metastatic Pancreatic Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This is a phase I clinical trial examining the safety, feasibility, and toxicity of gemcitabine and erlotinib when given in combination with capecitabine in adult patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Carcinoma
- What is being tested?
- gemcitabine, capecitabine and erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Histologically confirmed pancreatic adenocarcinoma that is metastatic or unresectable.
- Previously untreated with chemotherapy in the metastatic setting. Prior 5-fluorouracil (5-FU) or capecitabine treatment is allowed if: 1) it was given as part of a combined modality chemoradiation regimen and 2) no greater than 30% of bone marrow was included in the field and 3) the treatment free interval has been > 6 weeks
- Must have measurable disease, defined as at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
- Age greater than or equal to 18 years
- Because no dosing or adverse event data are currently available on the use of capecitabine in combination with gemcitabine and erlotinib in patients <18 years of age, children are excluded from this study. Pancreatic adenocarcinoma is primarily a disease of the elderly.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2 (Karnofsky greater than or equal to 60%).
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- Life expectancy > 8 weeks
- Must have normal organ and marrow function as defined below:
- leukocytes, greater than or equal to 3,000/μl
- absolute neutrophil count, greater than or equal to 1,500/μl
- platelets, greater than or equal to100,000/μl
- total bilirubin, less than or equal to 2.5 X institutional upper limit of normal
- AST(SGOT)/ALT(SGPT), less than or equal to 2.5 X institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT), less than or equal to 5 X institutional ULN in patients with liver metastasis
- creatinine, less than or equal to 1.5 X institutional ULN
- creatinine clearance, > 30 ml/min (Cockcroft-Gault method)
- Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential).
- Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue contraception for 30 days from the date of the last study drug administration.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior chemotherapy for pancreatic adenocarcinoma in the metastatic setting are not eligible.
- Chemoradiation within the last 6 weeks prior to registration are not eligible
- Known allergy or severe reactions to gemcitabine, capecitabine, or tyrosine kinase inhibitors are not eligible
- May not be receiving any other investigational agents or received investigational agents within the 28 days prior to registration.
- Known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events.
- Prior malignancy in the last 3 years, except basal cell carcinoma, squamous cell, or in-situ cervical cancer
Show all 12Show fewer
- ECOG PS 3-4
- 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.
- Pregnant women are excluded from this study because gemcitabine and capecitabine are Class D agents with the potential for teratogenic or abortifacient effects.
- Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with erlotinib or other agents administered during the study.
- Creatinine clearance < 30 ml/min (Cockcroft-Gault method)
- Patients that require ongoing (chronic) treatment with medications metabolized by CYP3A4 (saquinavir, ritonavir, nelfinavir, indinavir, ketoconazole, itraconazole, nefazodone, clarithromycin, atazanavir, rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, St. John's Wort) who cannot be switched to alternate medications that are not metabolized by CYP3A4 are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase I Trial of GemCap-T, Capecitabine in Combination With Gemcitabine and Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma
This is a phase I clinical trial examining the safety, feasibility, and toxicity of gemcitabine and erlotinib when given in combination with capecitabine in adult patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma.
Treatment will be administered at Moffitt on an outpatient basis and consists gemcitabine once per week for 3 weeks, followed by a week off treatment. Erlotinib (tablet) taken by mouth continuously starting with day one of cycle 1 with capecitabine taken twice per day on days 1-14 of each cycle followed by a 2 week off treatment rest period. An accelerated dose-escalation scheme will be employed with 4 planned dose levels. Whenever patients have been enrolled at a given dose with at most 1 DLT, the protocol will be stopped and the dose will be called the maximum tolerated dose (MTD). Patients will be treated at the recommended phase II dose (RPTD) to confirm tolerability at that dose.
In the absence of treatment delays due to adverse events, treatment may continue for 6 cycles or until disease progression and patients may continue on the study regimen unless they experience an adverse event that meets the criteria for a dose limiting toxicity.
Read the detailed description
This is a phase I clinical trial examining the safety, feasibility, and toxicity of gemcitabine and erlotinib when given in combination with capecitabine in adult patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma. This combination of drugs has never been used before.
Screening tests will consists of demographics, a medical history, and physical exam, vital signs, height, weight, performance status, blood counts, chemistries, and clotting. There will also be an electrocardiogram (EKG), tumor measurement (computed tomography [CT Scan] or magnetic resonance imaging [MRI] or positron emission tomography CT [PET-CT]), cancer antigen (CA 19-9), and a serum pregnancy test (for women of childbearing potential). Tumor measurements are also performed after cycle 2, 4, and 6 (study end).
Treatment will be administered on an outpatient basis and consists of both intravenous (IV) medication and tablets taken by mouth. The gemcitabine will be administered at Moffitt once per week for 3 weeks, followed by a week off treatment. One tablet of erlotinib will be taken by mouth continuously starting with day one of cycle 1 while capecitabine will be taken twice per day on days 1-14 of each cycle followed by a 2 week off treatment rest period. This set of treatments is called a cycle. One full cycle of treatment will last 28 days and a total of 6 cycles of treatments are planned. Before each cycle we will repeat the blood counts and a brief physical exam (vital signs) will be recorded weekly during the first 3 weeks of the 28 day cycle of treatment (when receiving Gemcitabine).
An accelerated dose-escalation scheme will be employed with 4 planned dose levels. Patients will be enrolled at the lowest dosage level, if no patients have unacceptable toxicity, the dose will be escalated and additional patients enrolled. If one of the patients at a given dose level experiences a dose limiting toxicity (DLT), more patients will be treated at that dose level. When 2 patients have DLTs at the same dose, the dose will be deescalated to the previous dose and additional patients will be enrolled. After de-escalation begins, whenever patients have been enrolled at a given dose with at most 1 DLT, the protocol will be stopped and the dose will be called the maximum tolerated dose (MTD). Patients will be treated at the recommended phase II dose (RPTD) to confirm tolerability at that dose.
In the absence of treatment delays due to adverse events, treatment may continue for 6 cycles or until disease progression. Patients may continue on the study regimen unless they experience an adverse event that meets the criteria for a dose limiting toxicity.
- Conditions
- Metastatic Pancreatic Carcinoma
- Being tested
- gemcitabine, capecitabine, erlotinib
- Keywords
- pancreatic, gemcitabine, erlotinib (HER1/epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor), capecitabine
- 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
Also called Gemzar®
Levels 1 through 4: 1000 mg/m^2
capecitabineDrug
Also called Xeloda
Level 1: 500 mg/m^2; Level 2: 825 mg/m^2; Level 3: 1000 mg/m^2; Level 4: 1250 mg/m^2
erlotinibDrug
Also called Tarceva®
Levels 1 through 4: 100 mg
| Study group | Role | What they receive |
|---|---|---|
| GemCap-T Dose Escalation | Experimental | GemCap-T, capecitabine in combination with gemcitabine. Dose Escalation 6 Cycles @ 28 Days. Receives: Drug: gemcitabine; Drug: capecitabine; Drug: erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The Maximum-tolerated dose (of capecitabine) is determined as the dose level at which two or more of six patients experience dose-limiting toxicity. The MTD will not exceed 1250 mg/m2.
Measured: Within 4 months of Cycle 1 Day 1 (C1D1)
Secondary outcomes (1)
Recommended Phase II Dose (RPTD)
To determine the recommended phase II dose (RPTD)of capecitabine when given in combination with gemcitabine and erlotinib. The recommended phase 2 dose is determined as the highest dose level below the MTD where 0-1 out of 6 patients have dose limiting toxicity (DLT).
Measured: Within 4 months of Cycle 1 Day 1 (C1D1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CarcinomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Gregory Springett, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480584
- Sponsor's protocol ID
- MCC-14624
- Other IDs
- OSI3482s
- Status last verified
- Nov 2012
- First submitted
- 29 May 2007
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of GemCap-T, Capecitabine in Combination With Gemcitabine and Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00480584
- Acronym / sponsor ID
- MCC-14624
- Conditions
- Metastatic Pancreatic Carcinoma
- Keywords
- pancreatic, gemcitabine, erlotinib (HER1/epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor), capecitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Apr 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 31 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I clinical trial examining the safety, feasibility, and toxicity of gemcitabine and erlotinib when given in combination with capecitabine in adult patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma.
Treatment will be administered at Moffitt on an outpatient basis and consists gemcitabine once per week for 3 weeks, followed by a week off treatment. Erlotinib (tablet) taken by mouth continuously starting with day one of cycle 1 with capecitabine taken twice per day on days 1-14 of each cycle followed by a 2 week off treatment rest period. An accelerated dose-escalation scheme will be employed with 4 planned dose levels. Whenever patients have been enrolled at a given dose with at most 1 DLT, the protocol will be stopped and the dose will be called the maximum tolerated dose (MTD). Patients will be treated at the recommended phase II dose (RPTD) to confirm tolerability at that dose.
In the absence of treatment delays due to adverse events, treatment may continue for 6 cycles or until disease progression and patients may continue on the study regimen unless they experience an adverse event that meets the criteria for a dose limiting toxicity.
Detailed description
This is a phase I clinical trial examining the safety, feasibility, and toxicity of gemcitabine and erlotinib when given in combination with capecitabine in adult patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma. This combination of drugs has never been used before.
Screening tests will consists of demographics, a medical history, and physical exam, vital signs, height, weight, performance status, blood counts, chemistries, and clotting. There will also be an electrocardiogram (EKG), tumor measurement (computed tomography [CT Scan] or magnetic resonance imaging [MRI] or positron emission tomography CT [PET-CT]), cancer antigen (CA 19-9), and a serum pregnancy test (for women of childbearing potential). Tumor measurements are also performed after cycle 2, 4, and 6 (study end).
Treatment will be administered on an outpatient basis and consists of both intravenous (IV) medication and tablets taken by mouth. The gemcitabine will be administered at Moffitt once per week for 3 weeks, followed by a week off treatment. One tablet of erlotinib will be taken by mouth continuously starting with day one of cycle 1 while capecitabine will be taken twice per day on days 1-14 of each cycle followed by a 2 week off treatment rest period. This set of treatments is called a cycle. One full cycle of treatment will last 28 days and a total of 6 cycles of treatments are planned. Before each cycle we will repeat the blood counts and a brief physical exam (vital signs) will be recorded weekly during the first 3 weeks of the 28 day cycle of treatment (when receiving Gemcitabine).
An accelerated dose-escalation scheme will be employed with 4 planned dose levels. Patients will be enrolled at the lowest dosage level, if no patients have unacceptable toxicity, the dose will be escalated and additional patients enrolled. If one of the patients at a given dose level experiences a dose limiting toxicity (DLT), more patients will be treated at that dose level. When 2 patients have DLTs at the same dose, the dose will be deescalated to the previous dose and additional patients will be enrolled. After de-escalation begins, whenever patients have been enrolled at a given dose with at most 1 DLT, the protocol will be stopped and the dose will be called the maximum tolerated dose (MTD). Patients will be treated at the recommended phase II dose (RPTD) to confirm tolerability at that dose.
In the absence of treatment delays due to adverse events, treatment may continue for 6 cycles or until disease progression. Patients may continue on the study regimen unless they experience an adverse event that meets the criteria for a dose limiting toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GemCap-T Dose Escalation | Experimental | Drug: gemcitabine, Drug: capecitabine, Drug: erlotinibGemCap-T, capecitabine in combination with gemcitabine. Dose Escalation 6 Cycles @ 28 Days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed pancreatic adenocarcinoma that is metastatic or unresectable.
- Previously untreated with chemotherapy in the metastatic setting. Prior 5-fluorouracil (5-FU) or capecitabine treatment is allowed if: 1) it was given as part of a combined modality chemoradiation regimen and 2) no greater than 30% of bone marrow was included in the field and 3) the treatment free interval has been > 6 weeks
- Must have measurable disease, defined as at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
- Age greater than or equal to 18 years
- Because no dosing or adverse event data are currently available on the use of capecitabine in combination with gemcitabine and erlotinib in patients <18 years of age, children are excluded from this study. Pancreatic adenocarcinoma is primarily a disease of the elderly.
Key exclusion criteria (12 listed)
- Prior chemotherapy for pancreatic adenocarcinoma in the metastatic setting are not eligible.
- Chemoradiation within the last 6 weeks prior to registration are not eligible
- Known allergy or severe reactions to gemcitabine, capecitabine, or tyrosine kinase inhibitors are not eligible
- May not be receiving any other investigational agents or received investigational agents within the 28 days prior to registration.
- Known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events.
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 |
|---|---|---|
| gemcitabineAlso: Gemzar®Levels 1 through 4: 1000 mg/m^2 | Drug | GemCap-T Dose Escalation |
| capecitabineAlso: XelodaLevel 1: 500 mg/m^2; Level 2: 825 mg/m^2; Level 3: 1000 mg/m^2; Level 4: 1250 mg/m^2 | Drug | GemCap-T Dose Escalation |
| erlotinibAlso: Tarceva®Levels 1 through 4: 100 mg | Drug | GemCap-T Dose Escalation |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Within 4 months of Cycle 1 Day 1 (C1D1)
The Maximum-tolerated dose (of capecitabine) is determined as the dose level at which two or more of six patients experience dose-limiting toxicity. The MTD will not exceed 1250 mg/m2.
1 secondary outcome
Recommended Phase II Dose (RPTD)
Time frame: Within 4 months of Cycle 1 Day 1 (C1D1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
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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.
Gregory Springett, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gemcitabine, capecitabine and erlotinib in people with Metastatic Pancreatic Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 19 inclusion and 12 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 8 Nov 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (MTD) (time frame: Within 4 months of Cycle 1 Day 1 (C1D1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2012.