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

This study is ongoing, but not recruiting participants.
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: December 17, 2013
Last verified: December 2013
  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:
  • Determine the progression free survival of patients with metastatic gastrointestinal, kidney, or lung cancer treated with of interferon-alfa-2b and 5-FU who have had disease progression on at least two prior systemic therapies. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the response rate, median duration of response, and median survival of patients treated with this regimen. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated 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-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
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.
  • 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 WBC 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, AST, 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

No publications provided

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
Last Updated: December 17, 2013
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:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Lung Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
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
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Fluorouracil
Reaferon

ClinicalTrials.gov processed this record on July 26, 2014