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

NCT01658813 | Completed Phase 2 Results

• 1 other identifier: 12-09
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Cancer Metastatic; Renal Cell Cancer Metastatic; Non Small Cell Lung Cancer Metastatic

Keywords

Metastatic Gastrointestinal; Metastatic Kidney; Metastatic Lung

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  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.

  Assessed up to 2 years

Secondary Outcomes (4)

• Number of Responses

  up to 2 years.

• Response Rate

  up to 2 years

• Median Duration of Response

  Up tp 2 years

• Median Survival

  up to 2 years

Study Arms (1)

5-Fluorouracil and Interferon

EXPERIMENTAL

5-Fluorouracil Interferon-alfa-2b

Drug: 5-Fluorouracil and Interferon

Interventions

5-Fluorouracil and Interferon DRUG

5-Fluorouracil Interferon-alfa-2b

Also known as: 5FU and Interferon

5-Fluorouracil and Interferon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Regional Medical Center: lead

Study Sites (1)

Western Regional Medical Center, Inc

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Interventions

Fluorouracil; Interferons

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Jessica L. Coats
• Organization: Western Regional Medical Center

jessica.coats@ctca-hope.com

623-207-3899

Study Officials

• Walter Quan, MD

  Western Regional Medical Center, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 7, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 21, 2018
• Results First Posted: July 25, 2016

Record last verified: 2018-01

Locations

US (1)