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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00025168

Enrollment

Registered

2003-01-27

Start date

2001-11-01

Completion date

2003-08-29

Last updated

2021-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancer

Brief 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.

Detailed 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.

Interventions

DRUGgemcitabine hydrochloride

DRUGirinotecan hydrochloride

RADIATIONradiation therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026