Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery - Full Text View

Sponsors and Collaborators:	Eastern Cooperative Oncology Group National Cancer Institute (NCI) Southwest Oncology Group Cancer and Leukemia Group B National Cancer Institute of Canada North Central Cancer Treatment Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00324805

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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 also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery.

Condition	Intervention	Phase
Lung Cancer	Drug: bevacizumab Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: vinorelbine ditartrate	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Docetaxel Cisplatin Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine Paclitaxel Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4cm)-IIIA Non-Small Lung Cancer (NSCLC)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	1500
Study Start Date:	June 2007
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients receive vinorelbine ditartrate IV over 10 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1, docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1.	Drug: carboplatin Given IV Drug: cisplatin Given IV Drug: docetaxel Given IV Drug: gemcitabine hydrochloride Given IV Drug: paclitaxel Given IV Drug: vinorelbine ditartrate Given IV
Arm II: Experimental Patients receive chemotherapy as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.	Drug: bevacizumab Given IV Drug: carboplatin Given IV Drug: cisplatin Given IV Drug: docetaxel Given IV Drug: gemcitabine hydrochloride Given IV Drug: paclitaxel Given IV Drug: vinorelbine ditartrate Given IV

Detailed Description:

OBJECTIVES:

Primary

Compare overall survival of patients with completely resected stage IB (tumors ≥ 4cm)-IIIA non-small cell lung cancer treated with adjuvant chemotherapy with or without bevacizumab.

Secondary

Compare disease-free survival of patients treated with these regimens.
Compare the toxicity of these regimens in these patients.
Perform analyses of tissue and blood to establish factors that predict clinical outcome in patients treated with these regimens.
Determine whether smoking status is linked to outcome in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type of chemotherapy (cisplatin/vinorelbine ditartrate vs cisplatin/docetaxel vs cisplatin/gemcitabine hydrochloride), stage (IB vs II vs IIIA [N2] vs IIIA [T3, N1]), histology (squamous cell vs other), and gender. Patients are randomized to 1 of 2 treatment arms.

Arm I (adjuvant chemotherapy without bevacizumab): Patients receive 1 of 3 chemotherapy regimens.
- Regimen 1: Patients receive vinorelbine ditartrate IV over 10 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1.
- Regimen 2: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1.
- Regimen 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1.

In all regimens, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Arm II (adjuvant chemotherapy with bevacizumab): Patients receive chemotherapy as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Patients complete smoking status questionnaires at baseline and then every 3 months during study treatment.

After completion of study treatment, patients are followed periodically for 10 years.

PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of stage IB-IIIA (T2-3 N0, T1-3 N1, T1-3 N3) non-small cell lung cancer (NSCLC)
- Patients with stage IB disease must have tumors measuring ≥ 4 cm
Must have undergone complete resection of NSCLC within the past 6-12 weeks
- Accepted types of resection include any of the following:
  - Lobectomy
  - Sleeve lobectomy
  - Bilobectomy
  - Pneumonectomy
- No resection by segmentectomy or wedge resection
Mediastinal lymph node sampling at specific levels is required pre-operatively (mediastinoscopy) or intraoperatively (level 7 for right-sided tumors or level 7 and 5 and/or 6 for left sided tumors)

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
INR ≤ 1.5 OR INR ≤ 3.0 with therapeutic anticoagulation
PTT normal
Bilirubin ≤ 1.5 mg/dL
AST and ALT < 5 times upper limit of normal (ULN)
Creatinine ≤ 1.5 times ULN
If urine protein:creatinine ratio > 0.5, then urine protein must be < 1,000 mg by 24-hour urine collection
No other cancer within the past 5 years except in situ carcinoma of the cervix or completely resected nonmelanoma skin cancer
Known history of myocardial infarction or other evidence of arterial thrombotic disease (angina) allowed if there is no evidence of active disease within the past 12 months
No history of cerebrovascular accident or transient ischemic attack
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 6 months after completion of study treatment
No clinically significant ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, psychiatric illness or social situation, or any other medical condition that would preclude study compliance
No history of bleeding diathesis or coagulopathy
No uncontrolled hypertension
- Hypertension allowed if well controlled (i.e., blood pressure < 150/90 mmHg) on a stable regimen of antihypertensive therapy
No serious nonhealing wound, ulcer, or bone fracture
No significant traumatic injury within the past 28 days
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
No ongoing postoperative hemoptysis (i.e., bright red blood of ≥ ½ teaspoon

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from prior surgery
No prior systemic chemotherapy
No hormonal cancer therapy or radiotherapy as cancer treatment within the past 5 years
- Prior surgery, biologic therapy, hormonal therapy, or radiotherapy for a malignancy diagnosed > 5 years prior to study entry that is now considered cured allowed
No major surgery or open biopsy within the past 28 days
- No anticipated major surgery during course of treatment
No core biopsy within the past 7 days
Concurrent therapeutic anticoagulation therapy allowed
No concurrent aminoglycoside antibiotics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324805

Show 722 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Southwest Oncology Group

Cancer and Leukemia Group B

National Cancer Institute of Canada

North Central Cancer Treatment Group

Investigators

Study Chair:	Heather A. Wakelee, MD	Stanford University
Investigator:	Alan B. Sandler, MD	Vanderbilt-Ingram Cancer Center
Study Chair:	David R. Gandara, MD	University of California, Davis
Investigator:	Eric Vallieres, MD, FRCSC	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Study Chair:	Stephen L. Graziano, MD	State University of New York - Upstate Medical University
Study Chair:	Charles A. Butts, MD, FRCPC	Cross Cancer Institute at University of Alberta
Study Chair:	Alex A. Adjei, MD, PhD	Roswell Park Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000475774, ECOG-E1505, SWOG-E1505, CALGB-E1505, CAN-NCIC-E1505, NCCTG-E1505
Study First Received:	May 10, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00324805
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Vinblastine
Bevacizumab
Carboplatin
Docetaxel
Vinorelbine

Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Paclitaxel
Lung Diseases
Gemcitabine
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents

Angiogenesis Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009