Hepatocellular CarcinomaPhase 1/2NCT00076609
Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma
A Phase 1/2 study testing PHY906 and capecitabine in people with Hepatocellular Carcinoma and Liver Cancer, run by PhytoCeutica at 5 sites in 2 countries.
Trial summary
Capecitabine is a chemotherapeutic that has been approved for use in breast and colorectal cancers. The advantages of capecitabine are that (1) it is an oral drug; and (2) it is less toxic than many other chemotherapeutics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer
- What is being tested?
- PHY906 and capecitabine
- How many people
- 31 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Oct 2003to not given
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women 18 to 80 years of age with a histologic or cytologic diagnosis of HCC or who meet all of the following criteria: (a) a-fetoprotein levels > 600 ng/mL; and (b) presence of cirrhosis or chronic hepatitis B or C; and (c) characteristic enhancement pattern of liver tumors on triphasic CT scan or MRI.
- All patients previously exposed to any prior anticancer treatments must have clear evidence of progressive disease after the most recent treatment regimen (see Exclusion Criteria).
- In the phase I (dose finding) and phase II (efficacy) portions of the study, patients may either have had no prior chemotherapy (chemotherapy naive), no prior capecitabine chemotherapy, or have been refractory to--or relapsed from--no more than two prior systemically administered treatment regimens. (Chemoembolization is not regarded in this context as a systemically administered treatment regimen.)
- All patients in both the phase I and phase II portions of this study must have at least one previously unirradiated, bidimensionally measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) scan of > 20 mm (if conventional CT scan) or more than or equal to 10 mm (if spiral CT scan). Triphasic spiral CT or MRI scans are preferred when such equipment is available. All CT scans should employ a "hepatoma protocol" image capture technique.
- Patients with central nervous system (CNS) involvement will have had appropriate treatment and will be free of progressive neurological deficits in the 28 days prior to enrollment.
- Patients with cirrhosis must have a Child-Pugh cirrhosis severity classification no greater than B.
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- Baseline performance status must be Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2.
- Life expectancy must be reasonably estimated to be > 12 weeks.
- Women patients who are known to be capable of conception should have a negative serum pregnancy test (beta-human chorionic gonadotropin [b-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.
Who cannot join
- Patients with an estimated (Cockroft and Gault equation) to the power of 40 or calculated baseline creatinine clearance of 30-50 mL/min should have the starting dose of capecitabine reduced to 750 mg/m2 BID X 14 days; the dose of PHY906 remains unchanged. Patients with a baseline creatinine clearance of less than 30 mL/min should not be enrolled in this trial.
- Patients with Child-Pugh cirrhosis severity classification of C.
- Baseline abnormalities in hepatic tests (AST > 5.0 X study center upper limit of normal (ULN); ALT > 5.0 X study center ULN; albumin < 2.8 g/dL; international normalized ratio for prothrombin time (INR) > 1.5 X study center ULN; total bilirubin > 3.0 x study center ULN).
- Baseline hemoglobin < 10.0 g/dL; total WBC < 2.0 X 10 to the power of 9/L; absolute neutrophil count (ANC) < 1.0 X 10 to the power of 9/L; or platelet count < 50.0 X 10 to the power of 9/L.
- Patients who are pregnant or breastfeeding.
- Any prior radiation therapy (other than small portals used for the palliation of isolated, symptomatic, osseous metastases) 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.
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- Patients may be either treatment naive or have had previous anticancer treatment; if previously treated they may not have been exposed to capecitabine and no more than two prior systemically administered treatment regimens are allowed. It is required that all treatment be completed no less than 21 days prior to the patient being treated in this study. Chemoembolization or hepatic resection are not regarded as systemically administered treatment regimens.
- Any treatment-related toxicity must have resolved within the 21 days 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 with known, untreated brain metastases are ineligible for this trial. Patients with treated (irradiated) brain metastases are eligible if treatment was completed more than 28 days prior to study entry and if clinical neurologic function is stable. No patient, however, may enroll in this trial if they are taking phenytoin (Dilantin). Patients with carcinomatous meningitis, treated or untreated, are excluded from the study.
- Patients with uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk.
- Patients receiving warfarin (Coumadin), or any of the coumarin-type anticoagulants at any dose, even "mini-dose," are excluded from this study because of a possible interference in their metabolism by capecitabine.
- Known allergy or hypersensitivity to PHY906 or any of the components used in the PHY906 formulations, or to capecitabine.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
City of Hope National Medical Center
Duarte, California, 91010
Yale University
New Haven, Connecticut, 06520
Stanford Hospital and Clinics
Stanford, California, 94305
VA Connecticut Cancer Center
West Haven, Connecticut, 06516
About this study
Official title: A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma
Capecitabine is a chemotherapeutic that has been approved for use in breast and colorectal cancers. The advantages of capecitabine are that (1) it is an oral drug; and (2) it is less toxic than many other chemotherapeutics. In an off-label hepatocellular carcinoma (HCC) clinical study, the response rate with capecitabine was 13%. The botanical drug PHY906--currently manufactured pursuant to GMP standards and regulations--has been used in China for over 1800 years to treat gastrointestinal-related ailments. Recently, preclinical studies demonstrated that PHY906 potentiates the anti-tumor effect of capecitabine. This trial will evaluate the safety and efficacy of PHY906 in enhancing the anti-tumor effects of capecitabine.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Being tested
- PHY906, capecitabine
- Keywords
- hepatocellular carcinoma, advanced, unresectable, liver cancer, systemic chemotherapy, botanical, herbal, alternative and complementary medicine, capecitabine, PHY906, oral, HCC, traditional chinese medicine, tcm, QOL, quality of life
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHY906Drug
capecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor imaging and evaluation every 6 weeks
Alphafetoprotein measurements every 3 weeks for first 3 courses, then every 6 weeks thereafter
Secondary outcomes (2)
QoL assessment every 3 weeks
Survival follow-up every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2004 (estimated)
- Study startOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants
Sponsor and investigators
- Lead sponsor
- PhytoCeutica
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076609
- Sponsor's protocol ID
- PHY906-2002-1
- Status last verified
- Mar 2007
- First submitted
- 27 Jan 2004
- Last updated
- 28 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00076609
- Acronym / sponsor ID
- PHY906-2002-1
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Keywords
- hepatocellular carcinoma, advanced, unresectable, liver cancer, systemic chemotherapy, botanical, herbal, alternative and complementary medicine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants
- Lead sponsor
- PhytoCeuticaIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- First posted
- 28 Jan 2004 (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.
Capecitabine is a chemotherapeutic that has been approved for use in breast and colorectal cancers. The advantages of capecitabine are that (1) it is an oral drug; and (2) it is less toxic than many other chemotherapeutics. In an off-label hepatocellular carcinoma (HCC) clinical study, the response rate with capecitabine was 13%. The botanical drug PHY906--currently manufactured pursuant to GMP standards and regulations--has been used in China for over 1800 years to treat gastrointestinal-related ailments. Recently, preclinical studies demonstrated that PHY906 potentiates the anti-tumor effect of capecitabine. This trial will evaluate the safety and efficacy of PHY906 in enhancing the anti-tumor effects of capecitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men or women 18 to 80 years of age with a histologic or cytologic diagnosis of HCC or who meet all of the following criteria: (a) a-fetoprotein levels > 600 ng/mL; and (b) presence of cirrhosis or chronic hepatitis B or C; and (c) characteristic enhancement pattern of liver tumors on triphasic CT scan or MRI.
- All patients previously exposed to any prior anticancer treatments must have clear evidence of progressive disease after the most recent treatment regimen (see Exclusion Criteria).
- In the phase I (dose finding) and phase II (efficacy) portions of the study, patients may either have had no prior chemotherapy (chemotherapy naive), no prior capecitabine chemotherapy, or have been refractory to--or relapsed from--no more than two prior systemically administered treatment regimens. (Chemoembolization is not regarded in this context as a systemically administered treatment regimen.)
- All patients in both the phase I and phase II portions of this study must have at least one previously unirradiated, bidimensionally measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) scan of > 20 mm (if conventional CT scan) or more than or equal to 10 mm (if spiral CT scan). Triphasic spiral CT or MRI scans are preferred when such equipment is available. All CT scans should employ a "hepatoma protocol" image capture technique.
- Patients with central nervous system (CNS) involvement will have had appropriate treatment and will be free of progressive neurological deficits in the 28 days prior to enrollment.
Key exclusion criteria (13 listed)
- Patients with an estimated (Cockroft and Gault equation) to the power of 40 or calculated baseline creatinine clearance of 30-50 mL/min should have the starting dose of capecitabine reduced to 750 mg/m2 BID X 14 days; the dose of PHY906 remains unchanged. Patients with a baseline creatinine clearance of less than 30 mL/min should not be enrolled in this trial.
- Patients with Child-Pugh cirrhosis severity classification of C.
- Baseline abnormalities in hepatic tests (AST > 5.0 X study center upper limit of normal (ULN); ALT > 5.0 X study center ULN; albumin < 2.8 g/dL; international normalized ratio for prothrombin time (INR) > 1.5 X study center ULN; total bilirubin > 3.0 x study center ULN).
- Baseline hemoglobin < 10.0 g/dL; total WBC < 2.0 X 10 to the power of 9/L; absolute neutrophil count (ANC) < 1.0 X 10 to the power of 9/L; or platelet count < 50.0 X 10 to the power of 9/L.
- Patients who are pregnant or breastfeeding.
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 |
|---|---|---|
| PHY906 | Drug | – |
| capecitabine | Drug | – |
Primary outcome
Tumor imaging and evaluation every 6 weeks
Alphafetoprotein measurements every 3 weeks for first 3 courses, then every 6 weeks thereafter
2 secondary outcomes
QoL assessment every 3 weeks
Survival follow-up every 2 months
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 28 Mar 2007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PHY906 and capecitabine in people with Hepatocellular Carcinoma and Liver Cancer, run by PhytoCeutica at 5 sites in 2 countries.
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 10 inclusion and 13 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 28 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Taiwan. 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?
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?
Tumor imaging and evaluation every 6 weeks. The study lists 2 primary outcomes in all. 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 28 Mar 2007.