A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Cisplatin; Drug: Bevacizumab; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661778

2006-005619-88 (EudraCT Number)

ML20081

Details and patient eligibility

About

This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m^2, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, ≥ 18 years of age.
• Stage IIIb or IV non-small cell lung cancer.
• Chemotherapy-naive.

Exclusion criteria

• Previous treatment for non-small cell lung cancer.
• Previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study.
• Recent or current chronic treatment with aspirin (> 325 mg/day).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Bevacizumab + cisplatin + docetaxel

Experimental group

Description:

Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.

Treatment:

Drug: Docetaxel

Drug: Cisplatin

Drug: Bevacizumab