Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00059826
First received: May 6, 2003
Last updated: June 12, 2015
Last verified: June 2015

May 6, 2003
June 12, 2015
March 2003
November 2010   (final data collection date for primary outcome measure)
Overall survival at 18 months [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00059826 on ClinicalTrials.gov Archive Site
  • Toxicity [ Time Frame: at 18 months ] [ Designated as safety issue: Yes ]
  • Disease-free survival [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
  • Local-regional disease control [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
  • Distant disease control [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer
A Phase II Study of Interferon-Based Adjuvant Chemoradiation in Patients With Resected Pancreatic Adenocarcinoma

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Radiation therapy uses high-energy radiation from x-rays and other sources to kill tumor cells. Combining chemotherapy with interferon alfa and giving them with radiation therapy after surgery may kill any remaining tumor cells.

PURPOSE: Phase II trial to study the effectiveness of adjuvant chemoradiotherapy and interferon alfa in treating patients who have resected stage I, stage II, or stage III pancreatic cancer.

OBJECTIVES:

  • Determine the disease-free and overall survival of patients with resected pancreatic adenocarcinoma treated with adjuvant chemoradiotherapy comprising fluorouracil, cisplatin, and interferon alfa.
  • Determine the rate and severity of acute and late toxic effects in patients treated with this regimen.
  • Determine the local-regional disease control and distant disease control in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Chemoradiotherapy (CRT): Patients receive fluorouracil IV continuously on days 1-38; cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36; and interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, and 38. Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38.
  • Post-CRT chemotherapy: Beginning 4-6 weeks after the completion of CRT, patients receive fluorouracil IV continuously on days 1-42. Treatment repeats every 56 days for a total of two courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Biological: interferon-alfa-2b
    IV
    Other Name: IFN-alpha-2b
  • Drug: cisplatin
    IV
  • Drug: 5-fluorouracil
    IV
    Other Name: 5-FU
  • Radiation: radiation therapy
    Other Name: XRT
Experimental: Interferon-based chemoradiation therapy

Cycle 1: Chemoradiotherapy (CRT)

  • 5-fluorouracil continuous infusion (CI) via an ambulatory infusion pump into a central venous catheter at 175 mg/m2/day for 38 consecutive days, unless toxicity occurs
  • cisplatin given on the first day only of each week of this cycle (days 1, 8, 15, 22, 29, 36)
  • IFN-alpha-2b 3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks
  • XRT 5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday - Friday, for 5½ weeks

Cycles 2 and 3: Post-CRT Chemotherapy

Post-CRT chemotherapy starts 4 - 6 weeks after completion of Cycle 1, unless the study physician deems further delay is necessary. Patients will be given 2 cycles of chemotherapy (cycles 2 and 3).

-- 5-fluorouracil continuous infusion via an ambulatory infusion pump into a central venous catheter at 200 mg/m2/day for 6 weeks followed by 2 weeks of rest

Interventions:
  • Biological: interferon-alfa-2b
  • Drug: cisplatin
  • Drug: 5-fluorouracil
  • Radiation: radiation therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
February 2011
November 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the head of the pancreas

    • Stage I, II, or III (T1-4, N0-1, M0)
    • No recurrent pancreatic cancer
  • Must have undergone a potentially curative gross total resection by pancreaticoduodenectomy within the past 56 days

    • Must have R0 (no residual tumor) or R1 (microscopic residual tumor) grade disease post-resection
  • No pancreaticoduodenectomy histopathology indicating any of the following types:

    • Adenosquamous carcinoma
    • Ampullary carcinoma
    • Carcinoid tumor
    • Cystadenocarcinoma
    • Cystadenoma
    • Distal common bile duct carcinoma
    • Duodenal carcinoma
    • Islet cell carcinoma
  • No metastatic disease by CT scan of the chest and CT scan with intravenous contrast (or MRI) of abdomen/pelvis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1 OR
  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 9.5 g/dL

Hepatic

  • Bilirubin no greater than 3 mg/dL
  • AST and ALT no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 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
  • Stable or increasing weight within 14 days before start of study treatment (otherwise supplemental nutrition, such as feeding jejunostomy, percutaneous endoscopic gastrostomy, or total parenteral nutrition, must be initiated)
  • No evidence of recurrence of any prior malignancy
  • No other malignancies within the past 5 years except successfully treated carcinoma in situ of the cervix, lobular carcinoma in situ of the breast, or nonmelanoma skin cancer
  • No preexisting psychiatric condition (especially depression) or a history of severe psychiatric disorders

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic or immunologic therapies
  • No concurrent biological response modifiers for pancreatic cancer
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No concurrent oprelvekin

Chemotherapy

  • No prior systemic chemotherapy for pancreatic cancer

Endocrine therapy

  • No concurrent dexamethasone

Radiotherapy

  • No prior radiotherapy for pancreatic cancer
  • No prior external beam photon (x-ray) therapy to the chest, abdomen, or pelvis
  • No concurrent intensity modulated radiotherapy

Surgery

  • See Disease Characteristics

Other

  • Underwent potentially curative therapy for any prior malignancies
  • No prior chronic immunosuppressive therapy (e.g., prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality
  • No concurrent theophylline
  • No concurrent aminoglycoside antibiotics
  • No concurrent halogenated antiviral agents (e.g., sorivudine)
  • No other concurrent investigational drugs for pancreatic cancer
  • No other concurrent systemic or loco-regional therapy for pancreatic cancer
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00059826
ACOSOG-Z05031, CDR0000298776
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Vincent J. Picozzi, MD Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center
Alliance for Clinical Trials in Oncology
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP