Gemcitabine, Cisplatin, Epirubicin, and Capecitabine in Treating Patients With Stage I-II Resectable Pancreatic Cancer

NCT01150630 | Completed Phase 2

• 3 other identifiers: CDR0000675485PACT-152010-019942-23
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, epirubicin hydrochloride, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine hydrochloride, with or without cisplatin, epirubicin hydrochloride, and capecitabine before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase II/III trial is studying how well gemcitabine hydrochloride, with or without cisplatin, epirubicin hydrochloride, and capecitabine, works when given before and/or after surgery in treating patients with stage I or stage II pancreatic cancer that can be removed by surgery.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage I pancreatic cancer; stage II pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Event-free survival at 1 year (phase II)

  CT scan

  every 3 months

Secondary Outcomes (6)

• Radiological, biochemical, and pathological response rate (neoadjuvant arm only)

  after 3 months of induction therapy

• Surgical resection rate

  immediately after surgery

• Surgical mortality and morbidity

  immediately after surgery

• Tolerability

  every 2 weeks during therapy

• Proportion of patients with negative surgical margins

  immediately after surgery

Study Arms (3)

adjuvant PEXG

EXPERIMENTAL

cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 6 months

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

perioperative PEXG

EXPERIMENTAL

cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 3 months before surgery and 3 months after surgery

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

Adjuvant Gemcitabine

ACTIVE COMPARATOR

Adjuvant Gemcitabine at 1000 mg/mq for 3 weeks every 4 weeks for 6 months

Drug: gemcitabine

Interventions

capecitabine DRUG

1250 mg/mq/day per os for 14 days every 14 days for 6 months

Also known as: XELODA

adjuvant PEXG; perioperative PEXG

cisplatin DRUG

30 mg/mq every 14 days for 6 months

Also known as: cisplatino TEVA

adjuvant PEXG; perioperative PEXG

epirubicin DRUG

30 mg/mq every 14 days for 6 months

Also known as: farmorubicina

adjuvant PEXG; perioperative PEXG

gemcitabine DRUG

ARM A: 1000 mg/mq for 3 weekly infusions every 4 weeks for 6 months ARM B and C: 800 mg/mq every 14 days for 6 months

Also known as: GEMZAR

Adjuvant Gemcitabine; adjuvant PEXG; perioperative PEXG

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 adenocarcinoma of pancreas * Stage I-II disease * Resectable disease * No superior mesenteric vein or artery, portal vein, celiac trunk, or hepatic artery infiltration * No symptomatic duodenal stenosis * NOTE: Patients without histological or cytological results may be allowed provided ≥ 1 attempt has been made by needle aspiration with negative imaging and clinical signs suggestive of adenocarcinoma. PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * WBC ≥ 3,500/mm³ * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL * Creatinine ≤ 1.5 mg/dL * ALT and AST ≤ 3 times upper limit of normal * Bilirubin ≤ 3 mg/dL * No prior or concurrent malignancy within the past 5 years except for surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin * Not pregnant or nursing * No psychological, familial, sociological, or geographical condition that would potentially hinder study compliance or follow-up schedule PRIOR CONCURRENT THERAPY: * 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, Balzano G, Zanon S, Zerbi A, Rimassa L, Castoldi R, Pinelli D, Mosconi S, Doglioni C, Chiaravalli M, Pircher C, Arcidiacono PG, Torri V, Maggiora P, Ceraulo D, Falconi M, Gianni L. Safety and efficacy of preoperative or postoperative chemotherapy for resectable pancreatic adenocarcinoma (PACT-15): a randomised, open-label, phase 2-3 trial. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):413-423. doi: 10.1016/S2468-1253(18)30081-5. Epub 2018 Apr 4.

  PMID: 29625841 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Cisplatin; 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; 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: June 24, 2010
• First Posted: June 25, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 1, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)