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Completed

NCT Number: NCT00786643

Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

The purpose of this study is to evalute the response and toxicity of metastatic colorectal cancer patients to the regimen of gamma interferon added to bolus and infusional 5-fluorouracil and leucovorin (GFL) with or without bevacizumab.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The West Clinic

Memphis, Tennessee, 38120, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Metastatic colorectal cancer, histologically or cytologically confirmed
  • Age 18 or greater
  • Adequate hematologic function (ANC > 1500, hemoglobin > 10 g/dl, platelet count > 100,000)
  • Adequate hepatic parameters (bilirubin < 2.0, Alk. Phos < 5 times normal, ALT < 5 times normal)
  • Adequate renal function (creatinine < 2.0)
  • Performance status ECOG 0-2
  • 0-2 prior lines of chemotherapy for metastatic colorectal cancer are allowed. Prior 5-FU/LV or capecitabine allowed either in the adjuvant setting, or in the metastatic setting or both.
  • Absence of other serious concurrent medical illnesses
  • Evaluable or measurable disease for phase I; measurable disease only for phase II

Exclusion criteria

  • Histologies other than adenocarcinoma
  • Previous grade 4 toxicity to 5-FU +/- LV or capecitabine
  • Uncontrolled brain metastases
  • Chronic diarrhea (greater than five bowel movements per day)
  • Previous chemotherapy or radiation therapy less than 4 weeks prior to study day 1 (less than 6 weeks for chemotherapy with Mitomycin or nitrosoureas)
  • Major surgery within 2 weeks before study entry
  • Known allergic sensitivity to leucovorin
  • Prior exposure to IFN-γ
  • Previous hematopoietic growth factor (e.g. epoetin alfa or darbepoietin less than 2 weeks prior to study day 1)
  • Pregnancy or breast feeding. Women of child-bearing potential must have a negative pregnancy test before the first dose.
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
  • Inability to provide written and informed consent
  • Uncontrolled hypertension
  • History of deep venous thrombosis or CVA
  • Prior exposure to bevacizumab
  • Proteinuria > 500 mg/24 hr

Treatment and study plan

5-fluorouracil

Drug

5-FU bolus was administered at 400mg/m^2 on day 1 and day 2 of each cycle. 5-FU at 600 mg/m^2 infusion was administered over 22 hours on day 1 and day 2 of each cycle.

Other names: Fluororacil, 5-FU

Leucovorin (LV)

Drug

Leucovorin 200mg/m^2 was administered over 2 hours on day 1 and day 2 of each cycle.

Other names: leucovorin calcium, folinic acid

Gamma-Interferon-1b (IFN-γ)

Drug

Gamma-Interferon 150 mcg/m^2 was administered by subcutaneous injection on day 1 of each cycle immediately before treatment with 5-FU and LV, and on day 3 of each cycle immediately after treatment with 5-FU and LV.

Other names: Gamma-Interferon-1b, Gamma-Interferon, Actimmune

Bevacizumab

Drug

Bevacizumab 5mg/kg was only added to the treatment regimen of patients in stratum 1 who demonstrated stable disease on imaging repeated prior to the 5th cycle of treatment. Bavacizumab was administered on day 4 of each cycle.

Other names: Avastin

Primary outcomes

  1. Best Response (BR)

    Time frame: After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)

    BR is recorded from start of treatment until progressive disease (PD). Imaging was repeated by same technique after every 4 cycles of treatment. Response was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0 and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; PD, increase in existing lesions or new lesions.

Secondary outcomes

  1. Early Response Rate (RR) (Stratum 1 Only)

    Time frame: After 4 cycles of treatment (approximately 56 days)

    Early RR evaluated in stratum 1 to see if bevacizumab (bev) would be added to GFL treatment (tx). Patients with stable disease (SD) pre 5th cycle of tx had bev added. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Per RECIST and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; SD, neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD), increase in existing lesions or new lesions.

  2. Time to Progression

    Time frame: From date of study treatment start until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months

    Patients were censored if they did not progress, stopped particiaption due to an adverse event, or withdrew consent following the start of study treatment. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0, Progressive Disease (PD) is defined as a measurable increase in smallest diameter of any target or non-target lesion, or the appearance of new lesions, since baseline.

Sponsors and collaborators

Lead sponsor

Accelerated Community Oncology Research Network

Other

Collaborators

  • InterMune

Registry information

Official study title

Phase II Study of Gamma Interferon (IFN-γ) Added to Bolus + Infusional 5-Fluorouracil (5-FU) and Leucovorin (LV) +/- Bevacizumab (BV) in Metastatic Colorectal Carcinoma

Acronym: GFL

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Nov 6, 2008
Registry last updated
Mar 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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