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Phase II Trial Of Adjuvant 2'2'-Difluoro-2'-Deoxycytidine (Gemcitabine) And External Beam Radiation For The Treatment Of Resectable Pancreatic Cancer


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

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Trial Information

Phase II Trial Of Adjuvant 2'2'-Difluoro-2'-Deoxycytidine (Gemcitabine) And External Beam Radiation For The Treatment Of Resectable Pancreatic Cancer


OBJECTIVES:

- Determine the time to disease progression, local control, and survival of patients with
previously resected pancreatic cancer treated with adjuvant gemcitabine and
radiotherapy.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29,
and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the
absence of disease progression or unacceptable toxicity.

Beginning at least 4 weeks after chemoradiotherapy, patients without disease progression and
with less than 10% weight loss during study receive additional gemcitabine IV over 30
minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.

Patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 or 3.4
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed invasive adenocarcinoma of the pancreas

- Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or
total pancreatectomy) within the past 2 months

- No clinical evidence of gross residual disease at time of surgery

- No focally positive margins (tumor at the margin)

- No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces,
or elsewhere

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0-2

Life expectancy:

- More than 6 months

Hematopoietic:

- Granulocyte count greater than 1,500/mm3

- Hemoglobin greater than 10 g/dL

- Platelet count greater than 100,000/mm3

Hepatic:

- Bilirubin less than 2.0 mg/dL

Renal:

- Creatinine less than 2.0 mg/dL

Other:

- Able to maintain adequate oral nutrition

- Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior
to study

- No other malignancy within the past 2 years except inactive nonmelanoma skin cancer
or carcinoma in situ of the cervix or breast

- Non-metastatic prostate cancer allowed if more than 2 year survival likely

- No other serious medical or psychiatric illness that would preclude study or limit
survival to less than 2 years

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent routine growth factors

Chemotherapy:

- No prior chemotherapy for pancreatic cancer

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior abdominal radiotherapy for pancreatic cancer

Surgery:

- See Disease Characteristics

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:

CDR0000068452

NCT ID:

NCT00010166

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage I pancreatic cancer
  • adenocarcinoma of the pancreas
  • Pancreatic Neoplasms

Name

Location

Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082