Epirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced, Metastatic, or Recurrent Solid Tumor

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00021047
• Other study ID #: 010172
• Secondary ID: NCI-01-C-0172MB-
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 11, 2001
• Last updated: March 7, 2012
• Start date: July 2001
• Est. completion date: June 2004

Study information

• Verified date: March 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 unresectable locally advanced, metastatic, or recurrent solid tumor.

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.

Other known NCT identifiers

• NCT00015743

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cholangiocarcinoma
• Esophageal Cancer
• Esophageal Neoplasms
• Extrahepatic Bile Duct Cancer
• Gastric Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Liver Cancer
• Liver Neoplasms
• Stomach Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• capecitabine

• carboplatin

• epirubicin hydrochloride

Locations

Country	Name	City	State
United States	Center for Cancer Research	Bethesda	Maryland
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	Naval Medical Center, Portsmouth	Portsmouth	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,