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A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gastric Cancer, Head and Neck Cancer, Liver Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Brian P. Monahan, MD, FACP

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

010172

NCT ID:

NCT00021047

Start Date:

July 2001

Completion Date:

June 2004

Related Keywords:

  • Esophageal Cancer
  • Extrahepatic Bile Duct Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Liver Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • recurrent verrucous carcinoma of the oral cavity
  • recurrent mucoepidermoid carcinoma of the oral cavity
  • recurrent adenoid cystic carcinoma of the oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV inverted papilloma of the paranasal sinus and nasal cavity
  • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent inverted papilloma of the paranasal sinus and nasal cavity
  • recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
  • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent salivary gland cancer
  • stage IV salivary gland cancer
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Liver Neoplasms
  • Stomach Neoplasms
  • Bile Duct Neoplasms

Name

Location

Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Center for Cancer ResearchBethesda, Maryland  20892