Know Cancer

or
forgot password

A Phase I Open-label Dose-escalation Study of Intravenous Aflibercept (AVE0005, VEGF Trap) in Combination With R-CHOP Administered Every 2 Weeks or Every 3 Weeks in Patients With Non Hodgkin's B-cell Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin

Thank you

Trial Information

A Phase I Open-label Dose-escalation Study of Intravenous Aflibercept (AVE0005, VEGF Trap) in Combination With R-CHOP Administered Every 2 Weeks or Every 3 Weeks in Patients With Non Hodgkin's B-cell Lymphoma


Inclusion Criteria:



- Patients with non-Hodgkin B-cell lymphoma, good condition, not previously treated

Exclusion Criteria:

- Contraindication to any drug contained in the R-CHOP
(Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal
Methotrexate)

- Less than 42 days elapsed from prior major surgery (28 days from other prior surgery)
to the time of inclusion

- Cerebral or leptomeningeal involvement.

- History of another neoplasm (Adequately treated basal cell or squamous cell skin
cancers, carcinoma in situ of the cervix, or any other cancer from which the patient
has been disease free for > 5 years are allowed)

- Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to the first drug intake

- Any acute or chronic medical condition, which could impair the ability of the patient
to participate to the study or could interfere with interpretation of study results

- Uncontrolled diabetes mellitus

- Uncontrolled hypertension

- Abnormal kidney function

- Evidence of clinically significant bleeding diathesis, non-healing wound or
underlying coagulopathy

- Pregnant or breast-feeding woman, or patient with reproductive potential (male,
female) without an effective method of contraception

- History of hypersensitivity to any Trap agents or recombinant proteins

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

selected dose of aflibercept based on Dose Limiting Toxicities observed

Outcome Time Frame:

cycle 1 +/- 2

Safety Issue:

Yes

Principal Investigator

Corinne Haioun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe d'Etudes du Lymphome de l'Adulte

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TCD10173

NCT ID:

NCT00644124

Start Date:

March 2008

Completion Date:

October 2011

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Non-Hodgkin's lymphoma
  • angiogenesis inhibitors
  • CHOP protocol
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location