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5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01658813
First received: August 2, 2012
Last updated: June 13, 2016
Last verified: June 2016
  Purpose
The purpose of this study is to determine whether the combination of a 5-Fluorouracil (5-FU) and interferon, which is able to stimulate the immune system to kill cancer cells, will help to increase tumor shrinkage in previously-treated metastatic gastrointestinal, kidney, or lung Cancer.

Condition Intervention Phase
Gastrointestinal Cancer Metastatic
Renal Cell Cancer Metastatic
Non Small Cell Lung Cancer Metastatic
Drug: 5-Fluorouracil and Interferon
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Chemoimmunotherapy With 5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer

Resource links provided by NLM:


Further study details as provided by Western Regional Medical Center:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: measured until progression ] [ Designated as safety issue: No ]
    Progression Free Survival (PFS) was calculated as the time (months) from date of the start of treatment to the date of first observed disease progression (per standard Response Evaluation Criteria In Solid Tumors [RECIST]. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.


Secondary Outcome Measures:
  • Number of Responses [ Time Frame: measured every 8 weeks until disease progression ] [ Designated as safety issue: No ]
    Radiographic studies to evaluate for response were done at 8 weeks (after 1 cycle). Standard RECIST response criteria were utilized.

  • Response Rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Radiographic studies to evaluate for response were done at 8 weeks (after 1 cycle). Standard RECIST response criteria were utilized.

  • Median Duration of Response [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
    Responding patients were reevaluated with radiographic studies every 8 weeks after response was first documented. Standard RECIST response criterial were utlized.

  • Median Survival [ Time Frame: from time of study entry until death ] [ Designated as safety issue: No ]
    Median survival was measured from date of entry on study until date of death


Enrollment: 18
Study Start Date: July 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-Fluorouracil and Interferon

5-Fluorouracil

Interferon-alfa-2b

Drug: 5-Fluorouracil and Interferon
5-Fluorouracil Interferon-alfa-2b

Detailed Description:
Interferon with continuous infusion 5-Fluorouracil (5-FU) regimens have shown response rates ranging from 0-43% in various cancers. Monthly bolus 5-FU + interferon-alfa-2b has not undergone formal phase II testing. In a small pilot study, a 5 consecutive day schedule of 5-FU and interferon-alfa-2b resulted in the limiting toxicities of diarrhea and mucositis. A more limited schedule was recommended. Therefore, it is reasonable to examine such a schedule. In the current study, 5-FU will be followed by interferon-alfa-2b daily for 3 days to attempt to benefit from both the biochemical and immunologic mechanisms described above.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically-proven, metastatic gastrointestinal, kidney, or lung cancer who have had disease progression on at least two prior systemic therapies.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and estimated survival of at least 3 months.
  • Patients must be felt to have recovered from effects of prior therapy, such as past expected white blood count nadir for chemotherapy (> 2 weeks for most agents, > 6 weeks for nitrosoureas or mitomycin-C)
  • Patient consent must be obtained prior to entrance onto study.
  • White blood count > 3500/mm3; platelet count of at least 100,000/mm3; hemoglobin > 9.0 gm/dl; bilirubin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) less than 3 times the upper limit of normal; serum creatinine < 1.8.
  • Corticosteroids and immunosuppressive agents are not permitted during the course of the study. Patients must have received no corticosteroids or immunosuppressive medications at least 2 weeks prior to entrance on-study.
  • Patients with elevated temperatures > 100.5 degrees F, must have sources of occult infection excluded.
  • Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment.

Exclusion Criteria:

  • Evidence of significant cardiovascular disease including history of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, or cerebrovascular accident.
  • Prior history of psychiatric disorder that could be exacerbated by interferon therapy or which could preclude completion of this therapy.
  • Pregnancy or lactation.
  • History of hypersensitivity to interferon alfa or fluoropyrimidines.
  • History of severe debilitating pulmonary disease, such as chronic obstructive pulmonary disease requiring continuous oxygen therapy.
  • History of autoimmune disease requiring immunosuppression.
  • Documented inflammatory joint or systemic inflammatory disease (such as Lupus) which could be exacerbated by interferon therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658813

Locations
United States, Arizona
Western Regional Medical Center, Inc
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Western Regional Medical Center
Investigators
Principal Investigator: Walter Quan, MD Western Regional Medical Center, Inc.
  More Information

Responsible Party: Walter Quan Jr., MD, Chief of Medical Oncology, Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01658813     History of Changes
Other Study ID Numbers: 12-09 
Study First Received: August 2, 2012
Results First Received: December 29, 2015
Last Updated: June 13, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Western Regional Medical Center:
Metastatic Gastrointestinal
Metastatic Kidney
Metastatic Lung

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Gastrointestinal Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Interferons
Fluorouracil
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 23, 2016