Adult Solid TumorPhase 3NCT00041171
Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
A Phase 3 study testing Hypericum perforatum and docetaxel in people with Adult Solid Tumor and Breast Cancer, run by Alliance for Clinical Trials in Oncology.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. St. John's wort may interfere with the effectiveness of chemotherapy. It is not yet known if chemotherapy is more effective with or without St. John's Wort in treating solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Adult Solid Tumor, Breast Cancer, Head and Neck Cancer
- What is being tested?
- Hypericum perforatum and docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed unresectable solid tumor, including, but not limited to, the following:
- Lung cancer
- Breast cancer
- Head and neck cancer
- Bladder cancer
- Prostate cancer
- Must be suitable for treatment with single-agent docetaxel
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- CTC 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than upper limit of normal (ULN)
- Alkaline phosphatase less than 2.5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
- BUN no greater than 1.5 times ULN
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior bone marrow transplantation
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No prior docetaxel
- No more than 2 prior chemotherapy regimens
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal agents except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes)
Radiotherapy:
- At least 3 weeks since prior radiotherapy
- No concurrent palliative radiotherapy
Surgery:
- At least 4 weeks since prior major surgery
Other:
- At least 6 months since prior Hypericum perforatum (St. John's Wort)
- At least 1 week since prior CYP3A enzyme inducers including:
- Phenobarbital
- Phenytoin
- Carbamazepine
- Lamotrigine
- Rifampin
- Rifabutin
- Isoniazid
- Sulfinpyrazone
- Pioglitazone
- Anti-HIV drugs such as efavirenz or nevirapine
- At least 1 week since prior CYP3A enzyme inhibitors including:
- Erythromycin
- Clarithromycin
- Azithromycin
- Roxithromycin
- Ketoconazole
- Fluconazole
- Itraconazole
- Metronidazole
- Chloramphenicol
- Ritonavir
- Saquinavir
- Indinavir
- Nelfinavir mesylate
- Delavirdine
- Amiodarone
- Cyclosporine
- Tacrolimus
- Sirolimus
- Nefazodone
- Fluvoxamine
- No concurrent CYP3A enzyme inducers
- No concurrent CYP3A enzyme inhibitors
- No ethanol (especially red wine), grape fruit juice, or seville orange juice (CYP3A enzyme inhibitor) within 3 days before or after receiving docetaxel
About this study
Official title: Phase III Randomized Study of Hypericum Perforatum (St. John's Wort) Combined With Docetaxel in Patients With Unresectable Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. St. John's wort may interfere with the effectiveness of chemotherapy. It is not yet known if chemotherapy is more effective with or without St. John's Wort in treating solid tumors.
PURPOSE: Randomized phase III trial to compare the effectiveness of docetaxel with or without St. John's wort in treating patients who have solid tumors that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
- Determine the effect of Hypericum perforatum (St. John's Wort) on the pharmacokinetic clearance of docetaxel in patients with unresectable solid tumors.
- Determine the effect of Hypericum perforatum on the production and plasma concentrations of M4-C13-hydroxydocetaxel in these patients.
- Determine the effects of this drug on the pharmacodynamics of docetaxel in these patients.
- Determine the relationship between the effects of this drug on docetaxel metabolic clearance and CYP3A4/CYP3A5 genotype in these patients.
- Determine the relationship between the effect of this drug on docetaxel metabolic clearance and p-glycoprotein genotype in these patients.
- Determine the relationship between the effect of this drug on docetaxel clearance and pregnane receptor genotype in these patients.
- Assess compliance with this drug in these patients.
- Assess the steady state concentrations of hyperforin, one of the putative psychoactive components of Hypericum perforatum, in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients who have not been receiving chronic Hypericum perforatum (St. John's Wort) are assigned to group A, while a cohort of 8 patients who have been receiving chronic Hypericum perforatum are assigned to group B.
- Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo three times daily on days 1-14 and docetaxel IV over 1 hour on day 15.
- Arm II: Patients receive oral Hypericum perforatum three times daily on days 1-14 and docetaxel as in arm I.
- Group B (non-randomized group): Patients receive docetaxel as in arm I and continue to receive their chronic regimen of Hypericum perforatum except on day 15.
Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for new primaries and survival only.
PROJECTED ACCRUAL: Approximately 92 patients will be accrued for this study.
- Conditions
- Adult Solid Tumor, Breast Cancer, Head and Neck Cancer, Kidney and Urinary Cancer, Male Reproductive Cancer, Thorax and Respiratory Cancer
- Being tested
- Hypericum perforatum, docetaxel, placebo
- Keywords
- stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer, recurrent non-small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage III bladder cancer, recurrent bladder cancer, stage IV bladder cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, unspecified adult solid tumor, protocol specific, untreated metastatic squamous neck cancer with occult primary, recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Urinary Bladder Neoplasms, Prostatic Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esthesioneuroblastoma, Olfactory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypericum perforatumDrug
docetaxelDrug
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: placebo + docetaxel | Experimental | Patients receive oral placebo three times daily on days 1-14 and docetaxel IV over 1 hour on day 15.
Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for new primaries and survival only. Receives: Drug: docetaxel; Other: placebo |
| Arm 2: Hypericum perforatum + docetaxel | Experimental | Patients receive oral Hypericum perforatum three times daily on days 1-14 and docetaxel as in arm 1.
Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for new primaries and survival only. Receives: Drug: Hypericum perforatum; Drug: docetaxel |
| Arm 3: Hypericum perforatum + docetaxel | Experimental | Patients receive docetaxel as in arm 1 and continue to receive their chronic regimen of Hypericum perforatum except on day 15.
Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for new primaries and survival only. Receives: Drug: Hypericum perforatum; Drug: docetaxel |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
Why it stopped: The study was not activated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Solid TumorStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lionel D. Lewis, MD, Study chair, Norris Cotton Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041171
- Sponsor's protocol ID
- CALGB-60002
- Other IDs
- CDR0000069449
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2002
- Last updated
- 12 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Hypericum Perforatum (St. John's Wort) Combined With Docetaxel in Patients With Unresectable Solid Tumors
- ClinicalTrials.gov ID
- NCT00041171
- Acronym / sponsor ID
- CALGB-60002
- Conditions
- Adult Solid Tumor, Breast Cancer, Head and Neck Cancer, Kidney and Urinary Cancer, Male Reproductive Cancer, Thorax and Respiratory Cancer
- Keywords
- stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer, recurrent non-small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage III bladder cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not activated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. St. John's wort may interfere with the effectiveness of chemotherapy. It is not yet known if chemotherapy is more effective with or without St. John's Wort in treating solid tumors.
PURPOSE: Randomized phase III trial to compare the effectiveness of docetaxel with or without St. John's wort in treating patients who have solid tumors that cannot be removed by surgery.
Detailed description
OBJECTIVES:
- Determine the effect of Hypericum perforatum (St. John's Wort) on the pharmacokinetic clearance of docetaxel in patients with unresectable solid tumors.
- Determine the effect of Hypericum perforatum on the production and plasma concentrations of M4-C13-hydroxydocetaxel in these patients.
- Determine the effects of this drug on the pharmacodynamics of docetaxel in these patients.
- Determine the relationship between the effects of this drug on docetaxel metabolic clearance and CYP3A4/CYP3A5 genotype in these patients.
- Determine the relationship between the effect of this drug on docetaxel metabolic clearance and p-glycoprotein genotype in these patients.
- Determine the relationship between the effect of this drug on docetaxel clearance and pregnane receptor genotype in these patients.
- Assess compliance with this drug in these patients.
- Assess the steady state concentrations of hyperforin, one of the putative psychoactive components of Hypericum perforatum, in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients who have not been receiving chronic Hypericum perforatum (St. John's Wort) are assigned to group A, while a cohort of 8 patients who have been receiving chronic Hypericum perforatum are assigned to group B.
- Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo three times daily on days 1-14 and docetaxel IV over 1 hour on day 15.
- Arm II: Patients receive oral Hypericum perforatum three times daily on days 1-14 and docetaxel as in arm I.
- Group B (non-randomized group): Patients receive docetaxel as in arm I and continue to receive their chronic regimen of Hypericum perforatum except on day 15.
Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for new primaries and survival only.
PROJECTED ACCRUAL: Approximately 92 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: placebo + docetaxel | Experimental | Drug: docetaxel, Other: placeboPatients receive oral placebo three times daily on days 1-14 and docetaxel IV over 1 hour on day 15. Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for new primaries and survival only. |
| Arm 2: Hypericum perforatum + docetaxel | Experimental | Drug: Hypericum perforatum, Drug: docetaxelPatients receive oral Hypericum perforatum three times daily on days 1-14 and docetaxel as in arm 1. Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for new primaries and survival only. |
| Arm 3: Hypericum perforatum + docetaxel | Experimental | Drug: Hypericum perforatum, Drug: docetaxelPatients receive docetaxel as in arm 1 and continue to receive their chronic regimen of Hypericum perforatum except on day 15. Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for new primaries and survival only. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Hypericum perforatum | Drug | Arm 2: Hypericum perforatum + docetaxel, Arm 3: Hypericum perforatum + docetaxel |
| docetaxel | Drug | Arm 1: placebo + docetaxel, Arm 2: Hypericum perforatum + docetaxel, Arm 3: Hypericum perforatum + docetaxel |
| placebo | Other | Arm 1: placebo + docetaxel |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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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.
Lionel D. Lewis, MD study chair
Norris Cotton Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypericum perforatum and docetaxel in people with Adult Solid Tumor and Breast Cancer, run by Alliance for Clinical Trials in Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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 12 Jul 2016.