Esophageal CancerPhase 1/2NCT00021047
Epirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced, Metastatic, or Recurrent Solid Tumor
A Phase 1/2 study testing capecitabine, carboplatin and epirubicin hydrochloride in people with Esophageal Cancer and Extrahepatic Bile Duct Cancer, run by National Institutes of Health Clinical Center (CC) at 3 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin, carboplatin, and capecitabine in treating patients who have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gastric Cancer
- What is being tested?
- capecitabine, carboplatin and epirubicin hydrochloride
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Jul 2001to Jun 2004
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor
- Progressive disease on standard therapy, including:
- Locally advanced, unresectable primary or recurrent tumor OR
- Metastatic disease
- Previously untreated metastatic cancer for which study regimen represents reasonable initial chemotherapy with palliative intent (e.g., metastatic gastric cancer, hepatobiliary cancer, or cancers for which no effective standard therapy exists) allowed
- Phase II portion:
- Diagnosis of cancer of the upper aerodigestive tract (head and neck, esophagus, stomach, or hepatobiliary)
- No potential curative treatment options including surgery, radiotherapy, chemoradiotherapy, or combination chemotherapy
- No leukemia or lymphoma
- No primary CNS malignancies or CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST and ALT no greater than 2.5 times upper limit of normal
Renal:
- Creatinine no greater than 1.6 mg/dL
Cardiovascular:
- LVEF at least 50%
- No symptomatic congestive heart failure
- No unstable angina
- No cardiac arrhythmia
Other:
- No serious concurrent medical illness that would preclude study participation
- No active infections requiring IV antibiotic therapy
- No history of allergy to platinum compounds, mannitol, or antiemetics used with study drugs
- No history of severe intolerance to fluorouracil
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- More than 4 weeks since prior immunotherapy and recovered
Chemotherapy:
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered
- No prior cumulative doxorubicin dose of more than 300 mg/m2
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy and recovered
- At least 8 weeks since prior strontium chloride Sr 89
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Other:
- At least 4 weeks since prior sorivudine or brivudine
- No concurrent sorivudine or brivudine
- No concurrent cimetidine
- No concurrent antiretroviral therapy for HIV-positive patients
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Center for Cancer Research
Bethesda, Maryland, 20889-5105
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-2197
About this study
Official title: A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin, carboplatin, and capecitabine in treating patients who have unresectable locally advanced, metastatic, or recurrent solid tumor.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and the recommended phase II dose of capecitabine administered with epirubicin and carboplatin in patients with unresectable locally advanced, metastatic, or recurrent solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics (PK) of capecitabine and correlate these PK parameters with clinical toxicity of this regimen in these patients.
- Correlate end-of-infusion levels of epirubicin and its metabolites with epirubicin dose and clinical toxicity of this regimen in these patients.
- Determine the possible correlation between polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of capecitabine.
Patients receive epirubicin IV over 2 hours and carboplatin IV over 30 minutes on day 1 and oral capecitabine twice daily on days 2-5, 8-12, and 15-19. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 24 additional patients are treated at the recommended phase II dose.
PROJECTED ACCRUAL: A total of 3-45 patients (24 patients for phase II) will be accrued for this study within 2 years.
- Conditions
- Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gastric Cancer, Head and Neck Cancer, Liver Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- capecitabine, carboplatin, epirubicin hydrochloride
- Keywords
- stage IV gastric cancer, recurrent gastric cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, unspecified adult solid tumor, protocol specific, untreated metastatic squamous neck cancer with occult primary, recurrent metastatic squamous neck cancer with occult primary, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV verrucous carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip
- Medical subject headings
- Esophageal Neoplasms, Bile Duct Neoplasms, Stomach Neoplasms, Head and Neck Neoplasms, Liver Neoplasms, Carcinoma, Hepatocellular, 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.
capecitabineDrug
carboplatinDrug
epirubicin hydrochlorideDrug
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)
- Study startJul 2001
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Brian P. Monahan, MD, FACP, National Cancer Institute (NCI)Eva Szabo, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021047
- Sponsor's protocol ID
- 010172
- Other IDs
- NCI-01-C-0172, MB-NAVY-00-07, MB-NAVY-B01-008, CDR0000068741
- Status last verified
- Mar 2012
- First submitted
- 11 Jul 2001
- Last updated
- 8 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients
- ClinicalTrials.gov ID
- NCT00021047
- Acronym / sponsor ID
- 010172
- Conditions
- Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gastric Cancer, Head and Neck Cancer, Liver Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- stage IV gastric cancer, recurrent gastric cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2001
- Study completion
- Jun 2004 (actual)
- 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin, carboplatin, and capecitabine in treating patients who have unresectable locally advanced, metastatic, or recurrent solid tumor.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and the recommended phase II dose of capecitabine administered with epirubicin and carboplatin in patients with unresectable locally advanced, metastatic, or recurrent solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics (PK) of capecitabine and correlate these PK parameters with clinical toxicity of this regimen in these patients.
- Correlate end-of-infusion levels of epirubicin and its metabolites with epirubicin dose and clinical toxicity of this regimen in these patients.
- Determine the possible correlation between polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of capecitabine.
Patients receive epirubicin IV over 2 hours and carboplatin IV over 30 minutes on day 1 and oral capecitabine twice daily on days 2-5, 8-12, and 15-19. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 24 additional patients are treated at the recommended phase II dose.
PROJECTED ACCRUAL: A total of 3-45 patients (24 patients for phase II) will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| capecitabine | Drug | – |
| carboplatin | Drug | – |
| epirubicin hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 8 Mar 2012.
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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.
Brian P. Monahan, MD, FACP
National Cancer Institute (NCI)
Eva Szabo, MD study chair
National Cancer Institute (NCI)
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 capecitabine, carboplatin and epirubicin hydrochloride in people with Esophageal Cancer and Extrahepatic Bile Duct Cancer, run by National Institutes of Health Clinical Center (CC) 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?
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 8 Mar 2012. 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 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.
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 8 Mar 2012.