Phase 2 Study of Endostar Combined With CHOP Regimen as the First Line Chemotherapy for Untreated Peripheral T Cell Lymphoma
Inclusion Criteria:
- Disease Characteristics:
- Diagnosis of peripheral T-cell:
- Any stage disease allowed
- At least 1 objective measurable disease parameter
- No anaplastic lymphoma kinase (ALK)-positive T-cell large cell lymphoma
- ALK-negative T-cell large cell lymphoma allowed
- No cutaneous T-cell lymphoma
- No sezary syndrome
- No NK/T cell lymphoma
- No history of or current radiographic evidence of CNS metastasis, including
previously treated, resected, or asymptomatic brain lesions or leptomeningeal
involvement
- Patient Characteristics:
- Age:
- 18 -75 years
- Performance status:
- ECOG 0-2
- Life expectancy:
- No less than 12 weeks
- Hematopoietic:
- Absolute neutrophil count ≥ 1,500/mm^3
- Hemoglobulin ≥ 80*10^12/L
- Platelet count ≥ 100,000/mm^3
- No evidence of bleeding diathesis or coagulopathy
- Hepatic:
- Bilirubin ≤ 1.5 mg/dL
- AST ≤ 2.5 times ULN
- PT, INR, and PTT ≤ 1.5 times normal
- Renal:
- Creatinine ≤ 1.5 times normal
- Cardiovascular:
- No cerebrovascular accident within the past 6 months
- No myocardial infarction within the past 6 months
- No unstable angina within the past 6 months
- No New York Heart Association class II-IV congestive heart failure
- No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm
Hg or diastolic BP > 100 mm Hg)
- No other clinically significant cardiovascular or peripheral vascular
disease
- LVEF is normal
- Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No history of active seizures
- No non-healing ulcer (unless involved with lymphoma)
- No active infection requiring parenteral antibiotics
- No known HIV positivity
- No other active malignancy within the past 6 months except carcinoma in
situ of the cervix or basal cell carcinoma of the skin
- PRIOR CONCURRENT THERAPY:
- Biologic therapy:
- Not specified
- Chemotherapy:
- No prior chemotherapy was allowed
- Surgery:
- More than 4 weeks since prior major invasive surgery or open biopsy
- At least 7 days since prior minor surgery
- No concurrent major surgery
Exclusion Criteria:
- Prior treatment included chemotherapy and radiotherapy
- With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g.,
myocardial infarction within the past 6 months, congestive heart failure treated with
medications, or uncontrolled hypertension)
- Pregnant or nursing
- Other currently active malignancy except nonmelanoma skin cancer
- Uncontrolled or severe bleeding,diarrhea,intestinal obstruction
- Hypersensitivity to albumen