We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658813
First Posted: August 7, 2012
Last Update Posted: December 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
  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: Intervention Model: Single Group Assignment
Masking: None (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 Walter Quan Jr., MD, Western Regional Medical Center:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: measured until progression ]
    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] or date of death from any cause, whichever came first, assessed up to 2 years. 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 or date of death from any cause, whichever came first, assessed up to 2 years. ]
    Radiographic studies to evaluate for response were done at 8 weeks (after 1 cycle). Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  • Response Rate [ Time Frame: 8 weeks ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 2, 2012
First Posted: August 7, 2012
Results First Submitted: December 29, 2015
Results First Posted: July 25, 2016
Last Update Posted: December 30, 2016
Last Verified: November 2016

Keywords provided by Walter Quan Jr., MD, 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