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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Arthur William Blackstock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000068933

NCT ID:

NCT00025168

Start Date:

November 2001

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Greenville Hospital SystemGreenville, South Carolina  29605
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534
Spartanburg Regional Healthcare SystemSpartanburg, South Carolina  29303