Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer

NCT00966706 | Completed Phase 2

• 3 other identifiers: CDR0000642240SRSI-PACT-92005-002586-36
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, capecitabine, gemcitabine hydrochloride, epirubicin hydrochloride, and docetaxel, 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. It is not yet known whether cisplatin, capecitabine, and gemcitabine hydrochloride are more effective when given together with epirubicin hydrochloride or docetaxel in treating patients with advanced or metastatic pancreatic cancer. PURPOSE: This randomized phase II trial is studying the side effects of giving cisplatin, capecitabine, and gemcitabine hydrochloride together with epirubicin hydrochloride compared with giving cisplatin, capecitabine, and gemcitabine hydrochloride together with docetaxel and to see how well it works in treating patients with stage III or stage IV pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage III pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival at 6-months

  CT scan

  every 2 months during therapy; every 3 months thereafter

Secondary Outcomes (3)

• Overall survival

  monthly

• Response rate

  every 2 months during therapy; every 3 months thereafter

• Toxicity

  every 2 weeks during therapy

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: capecitabine; Drug: cisplatin; Drug: docetaxel; Drug: gemcitabine hydrochloride

Arm II

EXPERIMENTAL

Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: capecitabine; Drug: cisplatin; Drug: epirubicin hydrochloride; Drug: gemcitabine hydrochloride

Interventions

capecitabine DRUG

Given systemically

Also known as: XELODA

Arm I; Arm II

cisplatin DRUG

Given systemically

Also known as: Cisplatino-TEVA

Arm I; Arm II

docetaxel DRUG

Given systemically

Also known as: TAXOTERE

Arm I

epirubicin hydrochloride DRUG

Given systemically

Also known as: FARMARUBICINA

Arm II

gemcitabine hydrochloride DRUG

Given systemically

Also known as: GEMZAR

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the pancreas * Stage III or IV disease * Measurable disease * No symptomatic brain metastases PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Adequate bone marrow, liver, and kidney function * Not pregnant or nursing * No other malignancies within the past 5 years except surgically treated carcinoma in situ of the cervix, and basal or squamous cell carcinoma of the skin * No multiple severe diseases that can compromise study safety, including any of the following: * Cardiac failure * Myocardial infarction within the past 4 months * Cardiac arrhythmia * History of psychiatric disabilities PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for pancreatic cancer * No other concurrent experimental drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Scientific Institute

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Cisplatin; Docetaxel; Epirubicin; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Michele Reni, MD

  Istituto Scientifico H. San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: June 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 1, 2012

Record last verified: 2009-08

Locations

IT (1)