Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin in Untreated NK/T Cell Lymphoma

Extranodal NK-T-CELL LYMPHOMA Clinical Trial

— Gifox-B  

Official title:

Phase II Trial of Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin (GIFOX-B)in Untreated NK/T Cell Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02808091
• Other study ID #: NCC1004
• Status: Terminated
• Phase: Phase 2
• First received: June 9, 2016
• Last updated: September 2, 2016
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: September 2016
• Source: National Cancer Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

• Assess responses, progression free survival (PFS) and overall survival (OS) of the combination of GIFOX-B chemotherapy with intensity-modulated radiation therapy (IMRT) in Stage IB or bulky disease - II and without IMRT in Stage III - IV.

• Assess the toxicity and maximum tolerated dose of bortezomib administered in combination with GIFOX chemotherapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria

1. Extranodal NK/T-cell lymphomas

2. Confirmed pathological diagnosis by the Department of Pathology SGH/NUH/TTSH.

3. Age more than or equals to 21 years.

4. Stages IB or bulky disease, II - IV

5. ECOG performance 0-2

6. Laboratory tests: ANC more than or equals to 1000/mm3, platelet more than or equals to 75,000/mm3. Creatinine less than or equals to 2x ULN or creatinine clearance more than or equals to 50 ml/min; AST and ALT less than or equals to 3x ULN. Total bilirubin < 1.5x ULN except < 3x ULN in patients with Gilbert's (as defined as > 80% unconjugated hyperbilirubinemia without other known cause); unless impairment is due to organ involvement by lymphoma.

7. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

1. Had prior systemic chemotherapy. Patients may be entered if they have had prior limited-field radiotherapy or a short course of glucocorticoids or single agent chemotherapy for an urgent local problem at diagnosis (e.g. epidural cord compression, superior vena caval syndrome).

2. History of peripheral neuropathy

3. HIV positive

4. Presence of CNS disease

5. Hypersensitivity to bortezomib, boron, or mannitol

6. Contraindication to any cytotoxic drug contained in the chemotherapy regimen.

7. Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and one year beyond treatment completion.

8. Female subject pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum ß-human chorionic gonadotrophin (ß-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for women without child-bearing potential.

9. Invasive or active malignancy in past 2 years.

10. Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extranodal NK-T-CELL LYMPHOMA
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• GIFOX-Bortezomib
GIFOX-Bortezomib will be given every 21 days for 4 cycles
• GIFOX-Bortezomib
GIFOX-Bortezomib will be given every 21 days for a total of 6 cycles.

Radiation:
• IMRT
a minimum of 50 Gy of IMRT to tumor bed and neck (5 weeks)

Locations

Country	Name	City	State
Singapore	National Cancer Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy with or without intensity-modulated radiation therapy (IMRT)	Assess the response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy together with intensity-modulated radiation therapy (IMRT) in stage IB or bulky disease - II patients and chemotherapy alone in stage III - IV patients.	3 years	No
Secondary	Progression free survival (PFS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients		3 years	No
Secondary	Overall survival (OS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients		5 years	No
Secondary	Toxicity of bortezomib administered in combination with GIFOX chemotherapy	Access the toxicity of treatment according to CTC AE 4.0	3 years	Yes