Pancreatic CancerPhase 1NCT00320749
Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer
A Phase 1 study testing Capecitabine, Docetaxel and Gemcitabine in people with Pancreatic Cancer, run by Tony Bekaii-Saab at 2 sites in United States.
Trial summary
The primary purpose of this study is to define the maximum tolerated dose of combination docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects will be measured in study participants. 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, Docetaxel and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2005to Jan 2011
- Phase
- Phase 1
- 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
- adenocarcinoma of the pancreas
- no prior chemo except adjuvant
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- peripheral neuropathy </= Gr. 1
Who cannot join
- Pregnant/lactating females
- Uncontrolled heart disease, diabetes, psychiatric disorder
- Therapeutic doses of Warfarin
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Ohio State University
Columbus, Ohio, 43210
About this study
Official title: A Dose Escalating (Phase I) Study Looking at the Biomodulation of Capecitabine by Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer
The primary purpose of this study is to define the maximum tolerated dose of combination docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects will be measured in study participants. In addition, researchers will assess data about preliminary efficacy in patients with this treatment approach.
Read the detailed description
Rationale: Single agent gemcitabine is considered standard care for patients with advanced pancreatic cancer. However, better treatments offering improved outcomes are needed for people with this disease. The combination of docetaxel and capecitabine has shown significant and broad clinical activity in a variety of tumors. Laboratory research on the combination of capecitabine, docetaxel, and gemcitabine indicates synergistic action against tumor cells. The current study will test this combination in patients. The drug administration schedule in this study is aimed at maximizing the potential of activation of capecitabine by both docetaxel and gemcitabine.
Treatment: Study participants will be given docetaxel, gemcitabine, and capecitabine. All study drugs will be administered through intravenous infusions in three week cycles. Docetaxel will be given on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. This schedule will be followed by 1 week of rest without administration of study drugs. Since the primary goal of this study is to identify the maximum tolerated dose of the study drugs in combination, patients who enroll in the beginning of the study will receive lower amounts of the study drugs compared to patients who enroll later in the study. Several tests and exams will be given throughout the study to closely monitor patients.
- Conditions
- Pancreatic Cancer
- Being tested
- Capecitabine, Docetaxel, Gemcitabine
- Keywords
- Advanced 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
Will be give on days 8-21
DocetaxelDrug
Also called Taxotere
Will be given on days 1 and 8,
GemcitabineDrug
Also called Gemzar
A fixed dose rate will be give on days 8 and 15.
| Study group | Role | What they receive |
|---|---|---|
| capecitabine, docetaxel, gemcitabine | Experimental | Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capcitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3. Receives: Drug: Capecitabine; Drug: Docetaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT).
Measured: Weekly up to 24 weeks
Secondary outcomes (2)
Common Toxicities
The NCI Common Terminology Criteria for Adverse Events version 3.0 was used for adverse event reporting and toxicity grading.
Measured: Weekly up to 24 weeks
Therapeutic Response
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; Overall Response (OR) = CR + PR.
Measured: every 8 weeks, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startDec 2005
- Primary completionOct 2008
- Study completionJan 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tony Bekaii-Saab
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan Rogel Cancer Center
- Responsible party
- Sponsor-investigator, Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
- Investigators
- Tanios Saab, Principal investigator, Ohio State UniversityTanios Saab, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320749
- Sponsor's protocol ID
- OSU-05058
- Status last verified
- May 2016
- First submitted
- 28 Apr 2006
- Last updated
- 27 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hill ME, Li X, Kim S, Campbell A, Culler K, Bloomston M, Zalupski M, Hejna G, Bekaii-Saab T. A phase I study of the biomodulation of capecitabine by docetaxel and gemcitabine (mGTX) in previously untreated patients with metastatic adenocarcinoma of the pancreas. Cancer Chemother Pharmacol. 2011 Mar;67(3):511-7. doi: 10.1007/s00280-010-1348-3. Epub 2010 May 12.
PubMed 20461379
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalating (Phase I) Study Looking at the Biomodulation of Capecitabine by Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer
- ClinicalTrials.gov ID
- NCT00320749
- Acronym / sponsor ID
- OSU-05058
- Conditions
- Pancreatic Cancer
- Keywords
- Advanced Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tony Bekaii-SaabUniversity, hospital or other
- Collaborators
- University of Michigan Rogel Cancer Center
- Study start
- Dec 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Posted 19 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to define the maximum tolerated dose of combination docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects will be measured in study participants. In addition, researchers will assess data about preliminary efficacy in patients with this treatment approach.
Detailed description
Rationale: Single agent gemcitabine is considered standard care for patients with advanced pancreatic cancer. However, better treatments offering improved outcomes are needed for people with this disease. The combination of docetaxel and capecitabine has shown significant and broad clinical activity in a variety of tumors. Laboratory research on the combination of capecitabine, docetaxel, and gemcitabine indicates synergistic action against tumor cells. The current study will test this combination in patients. The drug administration schedule in this study is aimed at maximizing the potential of activation of capecitabine by both docetaxel and gemcitabine.
Treatment: Study participants will be given docetaxel, gemcitabine, and capecitabine. All study drugs will be administered through intravenous infusions in three week cycles. Docetaxel will be given on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. This schedule will be followed by 1 week of rest without administration of study drugs. Since the primary goal of this study is to identify the maximum tolerated dose of the study drugs in combination, patients who enroll in the beginning of the study will receive lower amounts of the study drugs compared to patients who enroll later in the study. Several tests and exams will be given throughout the study to closely monitor patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capecitabine, docetaxel, gemcitabine | Experimental | Drug: Capecitabine, Drug: Docetaxel, Drug: GemcitabineDose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capcitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adenocarcinoma of the pancreas
- no prior chemo except adjuvant
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- peripheral neuropathy </= Gr. 1
Key exclusion criteria (3 listed)
- Pregnant/lactating females
- Uncontrolled heart disease, diabetes, psychiatric disorder
- Therapeutic doses of Warfarin
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: XelodaWill be give on days 8-21 | Drug | capecitabine, docetaxel, gemcitabine |
| DocetaxelAlso: TaxotereWill be given on days 1 and 8, | Drug | capecitabine, docetaxel, gemcitabine |
| GemcitabineAlso: GemzarA fixed dose rate will be give on days 8 and 15. | Drug | capecitabine, docetaxel, gemcitabine |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Weekly up to 24 weeks
MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT).
2 secondary outcomes
Common Toxicities
Time frame: Weekly up to 24 weeks
Therapeutic Response
Time frame: every 8 weeks, up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20461379Hill ME, Li X, Kim S, Campbell A, Culler K, Bloomston M, Zalupski M, Hejna G, Bekaii-Saab T. A phase I study of the biomodulation of capecitabine by docetaxel and gemcitabine (mGTX) in previously untreated patients with metastatic adenocarcinoma of the pancreas. Cancer Chemother Pharmacol. 2011 Mar;67(3):511-7. doi: 10.1007/s00280-010-1348-3. Epub 2010 May 12.
- JameslineLink provided by the sponsor.
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
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Tanios Saab principal investigator
Ohio State University
Tanios Saab, M.D. principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Capecitabine, Docetaxel and Gemcitabine in people with Pancreatic Cancer, run by Tony Bekaii-Saab at 2 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 4 inclusion and 3 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 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Yes. Results are posted in the registry (first posted 19 Oct 2015). 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?
Maximum Tolerated Dose (MTD) (time frame: Weekly up to 24 weeks). 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 NCT00320749, 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 27 Jun 2016.