Cisplatin, Irinotecan, and Bevacizumab, in Treating Patients With Small Cell Lung Cancer

Conditions

• Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cisplatin — DRUG
  Given IV
• irinotecan hydrochloride — DRUG
  Given IV
• bevacizumab — BIOLOGICAL
  Given IV
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

This phase II trial is studying how well giving cisplatin and irinotecan together with bevacizumab works in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of small cell lung cancer by blocking blood flow to the tumor. Giving cisplatin and irinotecan together with bevacizumab may kill more tumor cells.

Key Dates

Start date

Dec 31, 2004

Status verified

Dec 2012

Primary completion

Apr 30, 2007

Completion

Jul 31, 2011

Study Design

Enrollment

72 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (cisplatin, irinotecan hydrochloride, bevacizumab)
  Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Survival time [ Time Frame: The time beginning at randomization until death or last known follow-up, assessed up to 4 years ]

Locations (2)

Find similar trials in Chicago, IL

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