Capecitabine, Epirubicin, and Carboplatin in Treating Patients With Progressive, Unresectable, or Metastatic Cancer

NCT00486356 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 0284-04-FBP30CA036727
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, epirubicin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with epirubicin and carboplatin in treating patients with progressive, unresectable, or metastatic cancer.

Conditions

Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Gastric Cancer; Liver Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; recurrent gastric cancer; stage IV gastric cancer; advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer; recurrent extrahepatic bile duct cancer; unresectable extrahepatic bile duct cancer; recurrent gallbladder cancer; unresectable gallbladder cancer

Outcome Measures

Primary Outcomes (2)

• Recommended phase II dose of capecitabine

  Establish a recommended Phase II dose of oral capecitabine given twice daily on days 2-5, 8-12, and 15-19 in combination with fixed IV doses of epirubicin and carboplatin given day 1 of each 28-day cycle

  Every 28-days until first documented progression up to 63 months

• Toxicities of combined chemotherapy regimen

  Evaluate all toxicities associated with this combination chemotherapy regimen: 1 - mild, 2 - moderate, 3 = severe and 4 - life-threatening

  Every 28-days until first documented progression up to 63 months

Secondary Outcomes (4)

• End-of-infusion levels of epirubicin hydrochloride/metabolites and incidence of correlation with epirubicin hydrochloride dosing and clinical toxicity

  Each day of dosing up to 63 months

• Correlation of the pharmacokinetics (speed of appearance in the blood plasma and its concentration) of capecitabine with clinical toxicity

  Each day of dosing up to 63 months

• Incidence of Correlation between polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity

  Post-treatment up to 63 months

• Antitumor activity

  Prior to cycle 1, and then every two 28 day cycles up to 63 months

Study Arms (1)

Capecitabine, Epirubicin, and Carboplatin

EXPERIMENTAL

Determine the recommended phase II dose of capecitabine when given together with epirubicin and carboplatin in treating patients with progressive, unresectable, or metastatic cancer.

Drug: capecitabine; Drug: carboplatin; Drug: epirubicin hydrochloride; Genetic: microarray analysis; Genetic: polymorphism analysis; Other: pharmacological study

Interventions

capecitabine DRUG

Also known as: Xeloda

Capecitabine, Epirubicin, and Carboplatin

carboplatin DRUG

Also known as: Paraplatin

Capecitabine, Epirubicin, and Carboplatin

epirubicin hydrochloride DRUG

Also known as: Ellence

Capecitabine, Epirubicin, and Carboplatin

microarray analysis GENETIC

Capecitabine, Epirubicin, and Carboplatin

polymorphism analysis GENETIC

Capecitabine, Epirubicin, and Carboplatin

pharmacological study OTHER

Capecitabine, Epirubicin, and Carboplatin

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed cancer, meeting 1 of the following criteria:
• Disease that has progressed on standard therapy
• Locally advanced but unresectable primary or recurrent solid tumor
• Metastatic disease, including previously untreated metastatic disease for which study regimen represents reasonable initial chemotherapy with palliative intent (e.g., metastatic gastric cancer, hepatobiliary cancer, or cancer for which no effective standard therapy exists)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Absolute neutrophil count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• alanine aminotransferase (ALT) \& aspartate aminotransferase (AST) ≤ 2.5 times ULN
• Creatinine ≤ 1.6 mg/dL
• Left ventricular ejection fraction ≥ 50%
• Fertile patients must use effective contraception
• Recovered from prior therapy
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) or immunotherapy
• At least 2 weeks since prior radiotherapy

You may not qualify if:

• No other potentially curative treatment options available (e.g., surgery, radiotherapy, chemoradiotherapy, or combination chemotherapy)
• No leukemia or lymphoma
• No primary central nervous system (CNS) malignancies or CNS metastases
• No other medical illness that would preclude study treatment
• No active infection requiring IV antibiotic therapy unless the infection has resolved
• No history of allergy to platinum compounds, mannitol, or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
• No history of unexpectedly severe intolerance to fluorouracil
• Not pregnant or nursing/negative pregnancy test
• No prior doxorubicin at cumulative doses \> 300 mg/m²
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent cimetidine

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Nebraska Medical Center, Eppley Cancer Center

Omaha, Nebraska, 68198-6805, United States

Location

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms; Stomach Neoplasms; Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Capecitabine; Carboplatin; Epirubicin; Microarray Analysis; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Microchip Analytical Procedures; Investigative Techniques; DNA Fingerprinting; Genetic Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Jean L Grem, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 14, 2007
• Study Start: October 1, 2004
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

US (1)