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Phase II Trial of Chemoimmunotherapy With 5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Cancer Metastatic, Renal Cell Cancer Metastatic, Non Small Cell Lung Cancer Metastatic

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Trial Information

Phase II Trial of Chemoimmunotherapy With 5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Walter Quan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Western Regional Medical Center, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

12-09

NCT ID:

NCT01658813

Start Date:

July 2012

Completion Date:

December 2013

Related Keywords:

  • Gastrointestinal Cancer Metastatic
  • Renal Cell Cancer Metastatic
  • Non Small Cell Lung Cancer Metastatic
  • Metastatic Gastrointestinal
  • Metastatic Kidney
  • Metastatic Lung
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Lung Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary
  • Gastrointestinal Neoplasms

Name

Location

Western Regional Medical Center, IncGoodyear, Arizona  85338