Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer

NCT00026403 | Completed Phase 2

• 3 other identifiers: NCCTG-N9942NCI-2012-02426CDR0000069026
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 26

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• overall survival

  12 months

Secondary Outcomes (1)

• quality of life

  Up to 3 years

Study Arms (1)

radiotherapy + gemcitabine + cisplatin

EXPERIMENTAL

Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy. Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Drug: cisplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy

Interventions

cisplatin DRUG

radiotherapy + gemcitabine + cisplatin

gemcitabine hydrochloride DRUG

radiotherapy + gemcitabine + cisplatin

radiation therapy RADIATION

radiotherapy + gemcitabine + cisplatin

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed unresectable adenocarcinoma of the pancreas * No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin * Prior subtotal resection or gross residual disease * No microscopic residual disease only * No metastatic disease outside of planned study radiotherapy field PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST no greater than 3 times ULN Renal: * Creatinine no greater than 1.5 times ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to maintain adequate oral nutrition * No significant infection * No other medical condition that would preclude study * No other malignancy within the past 5 years except non-melanoma skin cancer * No significant nausea or vomiting PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior or concurrent biologic therapy Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior radiotherapy that would overlap planned study radiotherapy fields Surgery: * See Disease Characteristics * At least 21 days since prior laparotomy

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (26)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905-0001, United States

Location

CentraCare Health Plaza

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501-5505, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Cancer Center

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (2)

• Haddock MG, Swaminathan R, Foster NR, Hauge MD, Martenson JA, Camoriano JK, Stella PJ, Tenglin RC, Schaefer PL, Moore DF Jr, Alberts SR. Gemcitabine, cisplatin, and radiotherapy for patients with locally advanced pancreatic adenocarcinoma: results of the North Central Cancer Treatment Group Phase II Study N9942. J Clin Oncol. 2007 Jun 20;25(18):2567-72. doi: 10.1200/JCO.2006.10.2111.

  PMID: 17577035 RESULT

• Haddock MG, Swaminathan R, Alberts SR, et al.: Gemcitabine (Gem), cisplatin (Cis) and radiation therapy (RT) for patients with locally advanced pancreatic adenocarcinoma (ACA): a North Central Cancer Treatment Group (NCCTG) phase II study. [Abstract] J Clin Oncol 22 (Suppl 14): A-4121, 343s, 2004.

  RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cisplatin; Gemcitabine; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Therapeutics

Study Officials

• Michael G. Haddock, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2001
• First Posted: January 27, 2003
• Study Start: September 1, 2001
• Primary Completion: June 1, 2007
• Study Completion: July 1, 2009
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

US (25); CA (1)