Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

NCT00786643 | Completed Phase 2 Results DMC

• 1 other identifier: WITMMCC0301
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

Gamma Interferon; 5-FU; LV

Outcome Measures

Primary Outcomes (1)

• Best Response (BR)

  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.

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

Secondary Outcomes (2)

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

  After 4 cycles of treatment (approximately 56 days)

• Time to Progression

  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

Study Arms (2)

Stratum 1

EXPERIMENTAL

Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.

Drug: 5-Fluorouracil; Drug: Leucovorin (LV); Drug: Gamma-Interferon-1b (IFN-γ); Drug: Bevacizumab

Stratum 2

EXPERIMENTAL

Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.

Drug: 5-Fluorouracil; Drug: Leucovorin (LV); Drug: Gamma-Interferon-1b (IFN-γ)

Interventions

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.

Also known as: Fluororacil, 5-FU

Stratum 1; Stratum 2

Leucovorin (LV) DRUG

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

Also known as: leucovorin calcium, folinic acid

Stratum 1; Stratum 2

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.

Also known as: Gamma-Interferon-1b, Gamma-Interferon, Actimmune

Stratum 1; Stratum 2

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.

Also known as: Avastin

Stratum 1

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Accelerated Community Oncology Research Network: lead
• InterMune: collaborator

Study Sites (1)

The West Clinic

Memphis, Tennessee, 38120, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Fluorouracil; Leucovorin; Interferon-gamma; interferon gamma-1b; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage-Activating Factors; Lymphokines; Proteins; Biological Factors; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Limitations and Caveats

Enrollment to stratum 1 was closed early due to difficulty accruing the required number of patients in this stratum.

Results Point of Contact

• Title: Vice President of Scientific Affairs
• Organization: Accelerated Community Oncology Research Network, Inc.

mwalker@acorncro.com

901-435-5570

Study Officials

• Lee Schwartzberg, MD

  Vector Oncology

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 6, 2008
• Study Start: February 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 1, 2012
• Results First Posted: February 22, 2012

Record last verified: 2012-02

Locations

US (1)