Colorectal NeoplasmsPhase 1/2NCT00036517
Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
A Phase 1/2 study testing PHY906 in people with Colorectal Neoplasms and Diarrhea, run by PhytoCeutica at 3 sites in United States.
Trial summary
The triple combination chemotherapy of irinotecan, 5-fluorouracil and leucovorin (CPT-11/5-FU/LV or Saltz regimen) is the treatment of choice for patients with advanced colorectal cancer. Severe diarrhea, unfortunately, is a side effect of such treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms, Diarrhea
- What is being tested?
- PHY906
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2002to Mar 2003
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must:
- be between 18 and 75 years of age, inclusive, at the time of enrollment.
- have advanced colorectal carcinoma, which may be either measurable or non-measurable.
- not have received either CPT-11, FU, or other cytotoxic chemotherapy agents in any setting (including adjuvant) within 1 year prior to screening.
- have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- use an effective contraceptive method if the patients are of reproductive potential while enrolled in the study, since the potential effects of the herbs on a developing fetus are unknown.
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- have an estimated life expectancy of at least 20 weeks.
- provide written informed consent.
- have adequate organ function as indicated by the following laboratory values; these laboratory values must be obtained within 14 days prior to study enrollment:
- Bone marrow reserve: absolute granulocyte count (AGC) more than or equal to 1.5 X 10(to the power of 9)/L, platelet count more than or equal to 100 X 10 (to the power of 9)/L, and hemoglobin level more than or equal to 9 g/dL.
- Hepatic function: serum total bilirubin concentration no greater than 1.5 mg/dL, aspartate transaminase (AST or serum glutamic-oxaloacetic transaminase [SGOT]), and alanine transaminase (ALT or serum glutamic-pyruvic transaminase [SGPT]) levels no greater than grade 2 toxicity as determined from the NCI-CTC version 2.0.
- Renal function: serum creatinine level no greater than grade 2 toxicity as determined from the CTC version 2.0.
Who cannot join
- Patients who have or are:
- Gilbert syndrome (familial, non-hemolytic, acholuric jaundice).
- patients with enterostomies.
- untreated brain metastases or deteriorating neurological function after the completion of cranial irradiation.
- a woman who is currently pregnant and/or breast-feeding.
- active infections or any serious systemic disorder that, in the opinion of the principal investigator, are incompatible with the study product and/or procedures.
- used an investigational agent within 4 weeks of study entry.
- a known hypersensitivity to the study medication, its excipients, its analogs, or any of the component herbs.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615
Weill Cornell Medical Center
New York, New York, 10021
VA CT Cancer Center
West Haven, Connecticut, 06516
About this study
Official title: A Phase I/IIA, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover, Dose Escalation, Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
The triple combination chemotherapy of irinotecan, 5-fluorouracil and leucovorin (CPT-11/5-FU/LV or Saltz regimen) is the treatment of choice for patients with advanced colorectal cancer. Severe diarrhea, unfortunately, is a side effect of such treatment. Preclinical studies have indicated that the botanical drug PHY906 can reduce such diarrhea without compromising the effectiveness of the chemotherapy. The primary purpose of this clinical study is to evaluate the safety, tolerability and minimum effective dose of PHY906 when administered in conjunction with the Saltz regimen.
Read the detailed description
CPT-11/5-FU/LV is an active combination agent in the treatment of colorectal cancer, but one of its dose-limiting toxicities is diarrhea. PHY906 has been shown to reduce the severity of CPT-11-induced toxicity without compromising antitumor efficacy in in vivo animal models. Additionally, there has been a long historical experience in the Far East demonstrating safety of PHY906 in humans. Thus, we are conducting this double-blind, placebo-controlled study to evaluate the safety and tolerability of PHY906. This dose escalation study will also examine the effect of PHY906 (1.2, 2.4, and 3.6 g/day) on the pharmacokinetics of CPT-11 and 5-FU after concomitant administration with CPT-11, 5-FU, and LV, and on the severity of CPT-11-induced toxicities such as diarrhea.
- Conditions
- Colorectal Neoplasms, Diarrhea
- Being tested
- PHY906
- Keywords
- Stage III and Stage IV colorectal cancer, diarrhea, reduce, alleviate, modulate, Saltz regimen, CPT-11, irinotecan, camptosar, 5-fluorouracil, leucovorin, 5-FU, LV, chemotherapy, side effect, toxicity, botanical drug, herbal medicine, chinese herbal medicine, traditional chinese medicine
- Medical subject headings
- Colorectal Neoplasms, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHY906Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2002 (estimated)
- Study startFeb 2002
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- PhytoCeutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wayne D Brenckman, Jr., MD, Study director, Inveresk Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036517
- Sponsor's protocol ID
- PHY906-2000-1
- Status last verified
- Sep 2004
- First submitted
- 10 May 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIA, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover, Dose Escalation, Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00036517
- Acronym / sponsor ID
- PHY906-2000-1
- Conditions
- Colorectal Neoplasms, Diarrhea
- Keywords
- Stage III and Stage IV colorectal cancer, diarrhea, reduce, alleviate, modulate, Saltz regimen, CPT-11, irinotecan
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- PhytoCeuticaIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Study completion
- Mar 2003
- First posted
- 13 May 2002 (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.
The triple combination chemotherapy of irinotecan, 5-fluorouracil and leucovorin (CPT-11/5-FU/LV or Saltz regimen) is the treatment of choice for patients with advanced colorectal cancer. Severe diarrhea, unfortunately, is a side effect of such treatment. Preclinical studies have indicated that the botanical drug PHY906 can reduce such diarrhea without compromising the effectiveness of the chemotherapy. The primary purpose of this clinical study is to evaluate the safety, tolerability and minimum effective dose of PHY906 when administered in conjunction with the Saltz regimen.
Detailed description
CPT-11/5-FU/LV is an active combination agent in the treatment of colorectal cancer, but one of its dose-limiting toxicities is diarrhea. PHY906 has been shown to reduce the severity of CPT-11-induced toxicity without compromising antitumor efficacy in in vivo animal models. Additionally, there has been a long historical experience in the Far East demonstrating safety of PHY906 in humans. Thus, we are conducting this double-blind, placebo-controlled study to evaluate the safety and tolerability of PHY906. This dose escalation study will also examine the effect of PHY906 (1.2, 2.4, and 3.6 g/day) on the pharmacokinetics of CPT-11 and 5-FU after concomitant administration with CPT-11, 5-FU, and LV, and on the severity of CPT-11-induced toxicities such as diarrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- be between 18 and 75 years of age, inclusive, at the time of enrollment.
- have advanced colorectal carcinoma, which may be either measurable or non-measurable.
- not have received either CPT-11, FU, or other cytotoxic chemotherapy agents in any setting (including adjuvant) within 1 year prior to screening.
- have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- use an effective contraceptive method if the patients are of reproductive potential while enrolled in the study, since the potential effects of the herbs on a developing fetus are unknown.
Key exclusion criteria (8 listed)
- Gilbert syndrome (familial, non-hemolytic, acholuric jaundice).
- patients with enterostomies.
- untreated brain metastases or deteriorating neurological function after the completion of cranial irradiation.
- a woman who is currently pregnant and/or breast-feeding.
- active infections or any serious systemic disorder that, in the opinion of the principal investigator, are incompatible with the study product and/or procedures.
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 | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
Wayne D Brenckman, Jr., MD study director
Inveresk Research
3 sites 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 PHY906 in people with Colorectal Neoplasms and Diarrhea, run by PhytoCeutica at 3 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 12 inclusion and 8 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: stopped early, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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 was stopped early. Results are not available in the source record.
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.
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 24 Jun 2005.