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

NCT00118235 | Completed Phase 2

• 5 other identifiers: NCI-2012-02815CDR0000433341CALGB-30306U10CA031946P30CA014236
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Survival time

  Described using Kaplan-Meier curves.

  The time beginning at randomization until death or last known follow-up, assessed up to 4 years

• Failure-free survival

  Described using Kaplan-Meier curves.

  The time between randomization and the occurrence of disease progression, or death, whichever comes first, assessed up to 4 years

Secondary Outcomes (1)

• Frequency of toxicity, tabulated by the most severe occurrence

  Up to 4 years

Study Arms (1)

Treatment (cisplatin, irinotecan hydrochloride, bevacizumab)

EXPERIMENTAL

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.

Drug: cisplatin; Drug: irinotecan hydrochloride; Biological: bevacizumab; Other: laboratory biomarker analysis

Interventions

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (cisplatin, irinotecan hydrochloride, bevacizumab)

irinotecan hydrochloride DRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E

Treatment (cisplatin, irinotecan hydrochloride, bevacizumab)

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Treatment (cisplatin, irinotecan hydrochloride, bevacizumab)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (cisplatin, irinotecan hydrochloride, bevacizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have histologically or cytologically documented small cell carcinoma of the bronchus
• The extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive stage patients are defined as those patients with extrathoracic metastases, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy
• Measurable or Non-measurable Disease
• No prior chemotherapy or investigational therapy for SCLC
• Radiation therapy must have been completed at least three weeks before initiation of protocol therapy
• No major surgical procedure within 28 days prior to starting treatment and fully recovered
• No minor surgical procedure (mediastinoscopy or core biopsy) within 7 days prior to starting treatment
• ECOG performance status: 0-2
• No "currently active" second malignancy other than non-melanoma skin cancers
• No CNS metastases; patients with a history of CNS metastases will NOT be eligible even if they have completed a course of CNS radiotherapy; all patients will have a screening brain CT or MRI to rule out occult CNS metastases
• No recent history of CVA (within 6 months)
• No serious or non-healing wound ulcer or bone fracture
• Patients with a history of significant bleeding episodes (e.g., hemoptysis, bleeding diathesis, upper or lower GI bleeding) are not eligible; patients with trace blood in the sputum ("blood tinged sputum") are eligible
• No myocardial infarction or significant change in anginal pattern within one year or current congestive heart failure (NYHA Class 2 or higher)
• Patients with a history of hypertension must be well controlled (\< 150/90) on a stable regimen of anti-hypertensive therapy

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Interventions

Cisplatin; Irinotecan; Bevacizumab

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Neal Ready

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 11, 2005
• Study Start: December 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: July 1, 2011
• Last Updated: June 17, 2014

Record last verified: 2012-12

Locations

US (2)