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

Pancreatic Cancer Clinical Trial

Official title:

Phase II Trial Of Induction Gemcitabine/CPT-11 Followed By Twice-Weekly Infusion Gemcitabine And Concurrent External Beam Radiation For The Treatment Of Locally Advanced Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00025168
• Other study ID #: REBACDR0000068933
• Secondary ID: CCCWFU-57100NCI-
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2001
• Est. completion date: August 29, 2003

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in 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 and radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

Description:

OBJECTIVES:

• Determine the time to progression, local control, and survival of patients with locally advanced, unresectable pancreatic cancer treated with induction gemcitabine and irinotecan followed by gemcitabine and concurrent radiotherapy.

OUTLINE: Patients receive induction gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Within 2 weeks of completing induction chemotherapy, patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32. Patients undergo concurrent radiotherapy 5 days a week for 5.5 weeks.

Patients are followed every 8 weeks for 6 months and then every 3 months for 1.5 years.

PROJECTED ACCRUAL: Approximately 60-120 patients will be accrued for this study within 1-2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 29, 2003
• Est. primary completion date: August 29, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed locally advanced pancreatic cancer

• Regional (peri-pancreatic) lymph node involvement allowed

• Clinically or surgically staged and considered unresectable or inoperable

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 6 months

Hematopoietic:

• Granulocyte count at least 1,500/mm3

• Hemoglobin at least 10 g/dL

• Platelet count at least 100,000/mm3

Hepatic:

• Not specified

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• Not pregnant

• Fertile patients must use effective contraception

• No other concurrent or prior malignancy within the past 2 years except nonmelanoma skin cancer or in situ carcinoma of the cervix or breast

• No other serious medical or psychiatric illness that would preclude giving informed consent or limit survival to less than 2 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent anticancer immunotherapy

Chemotherapy:

• No prior chemotherapy

• No other concurrent anticancer chemotherapy

Endocrine therapy:

• No concurrent anticancer hormonal therapy

Radiotherapy:

• No prior abdominal-pelvic radiotherapy

• No other concurrent anticancer radiotherapy

Surgery:

• See Disease Characteristics

• At least 3 weeks since prior open abdominal surgery

• More than 10 days since prior laparoscopy

Other:

• No other concurrent investigational drug

• No concurrent participation in other clinical study

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• irinotecan hydrochloride

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	East Carolina University School of Medicine	Greenville	North Carolina
United States	Greenville Hospital System	Greenville	South Carolina
United States	Spartanburg Regional Healthcare System	Spartanburg	South Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mishra G, Butler J, Ho C, Melin S, Case LD, Ennever PR, Magrinat GC, Bearden JD, Minotto DC, Howerton R, Levine E, Blackstock AW. Phase II trial of induction gemcitabine/CPT-11 followed by a twice-weekly infusion of gemcitabine and concurrent external bea — View Citation