Pancreatic CancerPhase 1/2NCT00411762
A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma
A Phase 1/2 study testing Capecitabine and PHY906 in people with Pancreatic Cancer, run by Yale University at 1 site in United States.
Trial summary
The aim of this research project is to determine the amount of capecitabine (Xeloda) which can be given safely with PHY906 (investigational drug) on a novel schedule. It is also the aim of this research project to determine what the effects, good and/or bad, are of combining capecitabine (Xeloda) with PHY906… 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 PHY906
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2009
- Phase
- Phase 1/2
- 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
- Men or women ≥18 years of age with either a histologic or cytologic diagnosis of locally advanced or metastatic pancreatic adenocarcinoma. However, patients with other solid malignancies will be allowed to participate during the dose escalating Phase I part of the study, who had failed to respond to standard therapy or for which no standard therapy exists.
- In the phase I portion, patients may either have had no prior chemotherapy (chemotherapy naive), or have been refractory to or relapsed from standard chemotherapy, including capecitabine-based regimens. However, in the phase II portion of the study, only pancreatic cancer patients with prior gemcitabine therapy will be eligible. No prior 5-FU/capecitabine chemotherapy will be allowed EXCEPT previous adjuvant treatment with 5-FU or capecitabine (radiosensitizing dose) with radiation completed at least 6 weeks prior to study entry.
- All patients in both the phase I and phase II portions of this study must have at least one previously unirradiated, unidimensionally measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) scan of ≥ 20 mm (if conventional CT scan) or ≥ 10 mm (if spiral CT scan).
- Patients with biliary or gastro-duodenal obstruction must have drainage or by pass prior to starting chemotherapy.
- Patients with adequate hepatic function defined as
- AST/ALT ≤ 2.5 X ULN;
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- Total Bilirubin ≤ 2.0 XULN;
- Alkaline Phosphatase ≤ 5 X ULN (in presence of liver metastasis); or
- Alkaline Phosphatase ≤ 2.5 X ULN (in absence of liver metastasis).
- Patients should have an adequate renal function as indicated by a serum creatinine <1.6 mg/dL or calculated creatinine clearance ≥ 50 mL/min. (Calculated by Cockcroft-Gault equation).
- Baseline performance status must be Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2.
- Women patients who are known to be capable of conception should have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) within 2 weeks of starting the study; all patients should agree to use adequate non-estrogenic birth control methods, consistent with the institute's standard form of contraception if conception is possible during the study.
- Provide written informed consent prior to screening.
- Patients with adequate hematologic tests:
- Hemoglobin ≥ 9.0 g/dL;
- Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L;
- Platelet count ≥ 100.0 x 10 9/L;
Who cannot join
- Patients who are pregnant or breastfeeding.
- Any prior palliative radiation therapy (other than used in the adjuvant therapy of pancreatic cancer > 6 weeks) must have been completed more than 21 days before entry into the study and evaluable lesions must not have been included in the radiation portal.
- Patients with prior capecitabine therapy for pancreatic cancer (Phase II).
- Patients with active CNS metastases.
- Patients with known hypersensitivity or a history of marked intolerance to 5-FU are ineligible.
- Because cimetidine can decrease the clearance of 5-FU, patients should not enter on this study until cimetidine is discontinued.
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- Patients should not receive concurrent therapy with either sorivudine or brivudine, while receiving capecitabine. If a patient has received prior sorivudine or brivudine, then at least four weeks must elapse before the patient receives capecitabine therapy.
- Exclude sexually active males unwilling to practice contraception during the study.
- Lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
- Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias) or myocardial infarction within the last 12 months.
- No concurrent radiotherapy is allowed.
- Known DPD (dihydropyrimidine dehydrogenase) deficiency.
- Patients who have received any previous treatment consisting of standard chemotherapy (gemcitabine in Phase II study; others in Phase I) within 21 days or an investigational agent (Phase I) within 30 days on study. Toxicity related to the previous therapy must have resolved prior to study entry.
- Patients with previous or concurrent malignancy except for inactive non-melanoma skin cancer and/or in situ carcinoma of the cervix, or other solid tumor treated curatively and without evidence of recurrence within the last 3 years prior to study entry.
- Patients taking herbal medicine(s), including supplement(s), are eligible if they discontinue the herbal medicine(s)/supplement(s) at least 7 days prior to study entry.
- Known allergy or hypersensitivity to PHY906 or any of the components used in the PHY906 formulations, or to capecitabine.
- Serious concurrent medical illness, which would jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety.
- Patients with active infections requiring intravenous antibiotic therapy are not eligible until the infection has resolved.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, 06519
About this study
The aim of this research project is to determine the amount of capecitabine (Xeloda) which can be given safely with PHY906 (investigational drug) on a novel schedule. It is also the aim of this research project to determine what the effects, good and/or bad, are of combining capecitabine (Xeloda) with PHY906 (investigational drug) in the treatment of advanced pancreatic cancer.
PHY906 is a powder from plants sold as a health food supplement in the United States. PHY906 has been used in China, Taiwan and other Asian countries as traditional Chinese medicine for hundreds of years.
Read more
The other drug involved in this study, capecitabine is an oral form of chemotherapy already approved by FDA in the management of colorectal and breast cancer.
Laboratory studies in animal models have shown that the combination of capecitabine and PHY906 shrinks liver cancer, and a pilot clinical study is currently evaluating this combination in patients with liver cancer to define the benefit. PHY906 has also shown to decrease diarrhea related to chemotherapy in a small study performed in patients with colon cancer treated at the Yale Cancer Center. Our recent laboratory studies have also shown that the combination of capecitabine and PHY906 also shrink pancreatic tumors in mouse models. This prompted us to test the combination of capecitabine and PHY906 in patients with advanced pancreatic cancer to assess the benefit in survival as well as any decrease in side effects, such as diarrhea caused by capecitabine.
- Conditions
- Pancreatic Cancer
- Being tested
- Capecitabine, PHY906
- Keywords
- Pancreatic
- 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
PHY906Drug
Also called Traditional Chinese Medicine: Scutellaria baicalensis Georgi, Glycyrrhiza uralensis Fisch., Ziziphus jujuba Mill., and Paeonia lactiflora Pall
| Study group | Role | What they receive |
|---|---|---|
| PHY906 Administration | Experimental | PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle Receives: Drug: Capecitabine; Drug: PHY906 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression Free Survival
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 100 weeks
Secondary outcomes (1)
Median Overall Survival
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 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2009
- Study completionDec 2009
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 Yale UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- PhytoCeutica, National Comprehensive Cancer Network, Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Howard Hochester, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411762
- Sponsor's protocol ID
- 0512000905
- Status last verified
- Mar 2015
- First submitted
- 13 Dec 2006
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT00411762
- Acronym / sponsor ID
- 0512000905
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- PhytoCeutica, National Comprehensive Cancer Network, Roche Pharma AG
- Study start
- Dec 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Dec 2006 (estimated)
- Results
- Posted 27 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research project is to determine the amount of capecitabine (Xeloda) which can be given safely with PHY906 (investigational drug) on a novel schedule. It is also the aim of this research project to determine what the effects, good and/or bad, are of combining capecitabine (Xeloda) with PHY906 (investigational drug) in the treatment of advanced pancreatic cancer.
PHY906 is a powder from plants sold as a health food supplement in the United States. PHY906 has been used in China, Taiwan and other Asian countries as traditional Chinese medicine for hundreds of years.
The other drug involved in this study, capecitabine is an oral form of chemotherapy already approved by FDA in the management of colorectal and breast cancer.
Laboratory studies in animal models have shown that the combination of capecitabine and PHY906 shrinks liver cancer, and a pilot clinical study is currently evaluating this combination in patients with liver cancer to define the benefit. PHY906 has also shown to decrease diarrhea related to chemotherapy in a small study performed in patients with colon cancer treated at the Yale Cancer Center. Our recent laboratory studies have also shown that the combination of capecitabine and PHY906 also shrink pancreatic tumors in mouse models. This prompted us to test the combination of capecitabine and PHY906 in patients with advanced pancreatic cancer to assess the benefit in survival as well as any decrease in side effects, such as diarrhea caused by capecitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PHY906 Administration | Experimental | Drug: Capecitabine, Drug: PHY906PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Men or women ≥18 years of age with either a histologic or cytologic diagnosis of locally advanced or metastatic pancreatic adenocarcinoma. However, patients with other solid malignancies will be allowed to participate during the dose escalating Phase I part of the study, who had failed to respond to standard therapy or for which no standard therapy exists.
- In the phase I portion, patients may either have had no prior chemotherapy (chemotherapy naive), or have been refractory to or relapsed from standard chemotherapy, including capecitabine-based regimens. However, in the phase II portion of the study, only pancreatic cancer patients with prior gemcitabine therapy will be eligible. No prior 5-FU/capecitabine chemotherapy will be allowed EXCEPT previous adjuvant treatment with 5-FU or capecitabine (radiosensitizing dose) with radiation completed at least 6 weeks prior to study entry.
- All patients in both the phase I and phase II portions of this study must have at least one previously unirradiated, unidimensionally measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) scan of ≥ 20 mm (if conventional CT scan) or ≥ 10 mm (if spiral CT scan).
- Patients with biliary or gastro-duodenal obstruction must have drainage or by pass prior to starting chemotherapy.
- Patients with adequate hepatic function defined as
Key exclusion criteria (18 listed)
- Patients who are pregnant or breastfeeding.
- Any prior palliative radiation therapy (other than used in the adjuvant therapy of pancreatic cancer > 6 weeks) must have been completed more than 21 days before entry into the study and evaluable lesions must not have been included in the radiation portal.
- Patients with prior capecitabine therapy for pancreatic cancer (Phase II).
- Patients with active CNS metastases.
- Patients with known hypersensitivity or a history of marked intolerance to 5-FU 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: Xeloda | Drug | PHY906 Administration |
| PHY906Also: Traditional Chinese Medicine: Scutellaria baicalensis Georgi, Glycyrrhiza uralensis Fisch., Ziziphus jujuba Mill., and Paeonia lactiflora Pall | Drug | PHY906 Administration |
Primary outcome
Median Progression Free Survival
Time frame: Up to 100 weeks
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
1 secondary outcome
Median Overall Survival
Time frame: Up to 100 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Howard Hochester, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Capecitabine and PHY906 in people with Pancreatic Cancer, run by Yale University 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 17 inclusion and 18 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 Mar 2015. 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 combined 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.
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 27 Mar 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?
Median Progression Free Survival (time frame: Up to 100 weeks). 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 27 Mar 2015.