Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer

NCT00079040 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-02944ECOG-E3501E3501U10CA021115
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well giving cisplatin and etoposide together with bevacizumab works in treating patients with previously untreated extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. 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 deliver tumor-killing substances to them. Giving chemotherapy with a monoclonal antibody may kill more tumor cells.

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Alive and Progression-free (PF) at 6 Months

  Progression-free survival was defined to be the interval in months from the date of registration to the date of documented disease progression or to death without progression. Patients alive without progression at 6 months were included in the numerator when calculating the progression-free rate.

  6 months

Secondary Outcomes (2)

• Overall Survival

  Assessed every 3 months for 2 years, then every 6 months for 1 year

• Best Objective Response

  Assessed every 6 weeks

Study Arms (1)

Treatment (cisplatin, etoposide, bevacizumab)

EXPERIMENTAL

Chemotherapy: Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab therapy: Beginning concurrently with chemotherapy, patients receive bevacizumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity.

Drug: cisplatin; Drug: etoposide; Biological: bevacizumab; Other: laboratory biomarker analysis

Interventions

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (cisplatin, etoposide, bevacizumab)

etoposide DRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213

Treatment (cisplatin, etoposide, bevacizumab)

bevacizumab BIOLOGICAL

Given IV

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

Treatment (cisplatin, etoposide, bevacizumab)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (cisplatin, etoposide, bevacizumab)

Eligibility Criteria

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

You may qualify if:

• Histologic (or cytologic) proof of small cell lung cancer must be confirmed
• Patients must be clinically staged as extensive disease
• Patients must have measurable disease as defined by RECIST criteria; baseline scans/evaluation used to document measurable disease must be done within 4 weeks prior to registration; patients with measurable disease only or with both measurable and non-measurable disease are eligible
• Patients must have ECOG performance status of 0, 1, or 2
• Patients may not have had prior chemotherapy, immunotherapy, or biological therapy for lung cancer; previously irradiated lesions must not be the only site of measurable disease
• ANC \> 1500/mm\^3
• Platelets \>= 100,000/mm\^3
• Creatinine =\< 1.5 mg
• Total bilirubin =\< 1.5 mg
• Pregnant or breastfeeding women are excluded from the study because the agents used in this study may be teratogenic to a fetus or child and there is no information on the excretion of the agents or their metabolites into breast milk; all females of childbearing potential must have a blood test or urine study within 2 weeks, prior to registration to rule out pregnancy
• Women of childbearing potential and sexually active males are strongly advised to use an effective method of contraception
• Patients must be disease-free for \> 5 years if they have a history of prior malignancies (except for cured basal or squamous cell skin cancers, or carcinoma in situ of the cervix)
• Patients must be considered on psychosocial grounds to be willing and able to comply with the requirements of treatment and follow-up
• Patients must not have CNS metastases; a head CT is required within 4 weeks prior to study entry for evaluation (MRIs are also acceptable)
• Urine dipstick for proteinuria of less than 1+ is required within 7 days prior to study entry; if urine dipstick is \>= 1+ then a 24 hour urine for protein must demonstrate =\< 1 gm of protein in 24 hours to allow participation in the study; NOTE: Urinalysis is also acceptable

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Cisplatin; Etoposide; Bevacizumab

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Statistician
• Organization: ECOG Statistical Office

617-632-3012

Study Officials

• Alan Sandler

  Eastern Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: March 8, 2004
• First Posted: March 9, 2004
• Study Start: January 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 14, 2014
• Results First Posted: February 2, 2010

Record last verified: 2012-12

Locations

US (1)