Gemcitabine or Combination Chemotherapy Followed by Chemoradiation for Stage IB, II, or III Pancreatic Cancer

NCT00960284 | Completed Phase 2

• 2 other identifiers: CDR0000641309PACT-7
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, epirubicin hydrochloride, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether gemcitabine hydrochloride is more effective when given alone or together with combination chemotherapy and radiation therapy in treating patients with pancreatic cancer. PURPOSE: This randomized phase II/III trial is studying gemcitabine hydrochloride to see how well it works when given alone or together with combination chemotherapy and radiation therapy in treating patients with stage IB, stage II, or stage III pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

stage IB pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas

Outcome Measures

Primary Outcomes (1)

• 1-year progression-free survival (Phase II)

  every 3 months during the first 2 years, every 6 months afterwards

Secondary Outcomes (1)

• Pattern of relapse

  every 3 months during the first 2 years, every 6 months afterwards

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive gemcitabine hydrochloride IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Drug: gemcitabine hydrochloride

Arm II

EXPERIMENTAL

Patients receive cisplatin IV over 1 hour and epirubicin hydrochloride IV on day 1 and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Patients also receive fluorouracil IV continuously beginning on day 1 or oral capecitabine. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

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

Interventions

capecitabine DRUG

Given orally

Also known as: XELODA

Arm II

cisplatin DRUG

Given IV

Also known as: Cisplatino-TEVA

Arm II

epirubicin hydrochloride DRUG

Given IV

Also known as: Farmarubicina

Arm II

fluorouracil DRUG

Given IV

Also known as: FLuorouracile-TEVA

Arm II

gemcitabine hydrochloride DRUG

Given IV

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 confirmed adenocarcinoma of the pancreas * Stage IB-III disease * Has undergone surgery with radical intent (R0 or R1) within the past 2 months PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% (90-100% for patients 71-75 years of age) * WBC ≥ 3,500/mm\^3 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Creatinine ≤ 1.5 mg/dL * Bilirubin ≤ 2 mg/dL * SGOT and SGPT ≤ 2 times upper limit of normal * Not pregnant or nursing * No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin * No psychological, familial, sociological, or geographical condition that would potentially hinder study compliance or follow-up schedule PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy or radiotherapy for pancreatic adenocarcinoma * 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)

Istituto Scientifico H. San Raffaele

Milan, 20132, Italy

Location

Related Publications (1)

• Reni M, Passoni P, Bonetto E, Balzano G, Panucci MG, Zerbi A, Ronzoni M, Staudacher C, Villa E, Di Carlo V. Final results of a prospective trial of a PEFG (Cisplatin, Epirubicin, 5-Fluorouracil, Gemcitabine) regimen followed by radiotherapy after curative surgery for pancreatic adenocarcinoma. Oncology. 2005;68(2-3):239-45. doi: 10.1159/000086780. Epub 2005 Jul 7.

  PMID: 16015040 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Cisplatin; Epirubicin; Fluorouracil; 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; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; 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 14, 2009
• First Posted: August 17, 2009
• Study Start: June 1, 2003
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 13, 2012

Record last verified: 2012-01

Locations

IT (1)