Biomarker-Integrated Approach of Targeted Therapy for Lung Cancer Elimination Plus External Beam Radiation Therapy (BATTLE-XRT)
Phase I/II Trial Using a Biomarker-Integrated Approach of Targeted Therapy for Lung Cancer Elimination Plus External Beam Radiation Therapy (BATTLE-XRT)
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of onartuzumab that can be given with erlotinib and standard chemoradiation (paclitaxel and carboplatin) to patients with NSCLC. The goal of Phase II is to learn if onartuzumab plus erlotinib and chemoradiation can help to control NSCLC. The safety of this drug will also be studied.
Trial Health
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2014
CompletedFirst Posted
Study publicly available on registry
January 24, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedApril 24, 2014
April 1, 2014
5 years
January 22, 2014
April 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) of Onartuzumab with Chemoradiation Therapy and Erlotinib
Maximum tolerated dose measured by the number and percent of patients experiencing dose-limiting toxicity (DLT). DLT defined as grade 3 or worse non-hematological toxicities or grade 4 or worse hematological toxicities (including all toxicities attributed to chemoradiation occurring up to 14 days of the end of radiation therapy).
6 months
Secondary Outcomes (1)
Progression-Free Survival (PFS)
6 months
Study Arms (2)
Chemoradiation + Onartuzumab
EXPERIMENTALParticipants with wild-type EGFR mutation to be randomized, and may receive this regimen. Phase I: Starting dose of Onartuzumab 10 mg/kg by vein on Day 1 of each 3 week cycle. Paclitaxel 45 mg/m2 by vein once a week throughout radiation for 7 weeks. Carboplatin AUC 2 by vein once a week throughout radiation for 7 weeks. Radiation therapy at 66 Gy in 33 fractions delivered 5 days a week for 7 weeks, or proton therapy delivered at biological equivalent to 66 Gy (RBE) (RBE = 1.1) in 33 fractions 5 days a week for 7 weeks. Phase II: Same regimen as in Phase I, but starting dose of Onartuzumab is maximum tolerated dose from Phase I.
Chemoradiation + Erlotinib + Onartuzumab
EXPERIMENTALParticipants with EGFR mutation to receive this regimen. Participants with wild-type EGFR mutation to be randomized, and may receive this regimen. Phase I: Erlotinib 150 mg by mouth every day throughout radiation, except for chemotherapy day. Starting dose of Onartuzumab 10 mg/kg by vein on Day 1 of each 3 week cycle. Paclitaxel 45 mg/m2 by vein once a week throughout radiation for 7 weeks. Carboplatin AUC 2 by vein once a week throughout radiation for 7 weeks. Radiation therapy at 66 Gy in 33 fractions delivered 5 days a week for 7 weeks, or proton therapy delivered at biological equivalent to 66 Gy (RBE) (RBE = 1.1) in 33 fractions 5 days a week for 7 weeks. Phase II: Same regimen as in Phase I, but starting dose of Onartuzumab is maximum tolerated dose from Phase I.
Interventions
Phase I: Starting dose of Onartuzumab 10 mg/kg by vein on Day 1 of each 3 week cycle. Phase II: Maximum tolerated dose from Phase I.
Phase I and II: 150 mg by mouth every day throughout radiation, except for chemotherapy day.
Phase I and II: 45 mg/m2 by vein once a week throughout radiation for 7 weeks.
Phase I and II: AUC 2 by vein once a week throughout radiation for 7 weeks.
Phase I and II: Radiation therapy at 66 Gy in 33 fractions delivered 5 days a week for 7 weeks, or proton therapy delivered at biological equivalent to 66 Gy (RBE) (RBE = 1.1) in 33 fractions 5 days a week for 7 weeks.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas) and poorly differentiated (not otherwise specified, NOS) non-small cell lung cancer; totally resected tumors are excluded. Patients should have tumor tissue for biomarker testing if available. Archival samples may be used. Patients without tissue for biomarker testing may be enrolled at the discretion of the investigator. The determination of MET status should be done by a pathologist who is trained in using the SP44 antibody with the Ventana platform and using the Ventana/Genentech algorithm.
- Patients with T1or T2 disease with N2 or T3N1-2 disease (Stage IIIA) are eligible if they are deemed inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable. Patients may have limited stage M1 disease, with a maximum of 3 metastatic sites (including the single brain mets) only if the other sites are to be treated with definitive intent, unless they are no longer clinically present secondary to induction chemotherapy. Treatment to the other sites can be delivered prior to or after this trial. Measurable disease is required. See Response Evaluation Criteria in Solid Tumors (RECIST) definitions of measurable disease.
- Patients must be \>/=18 years of age.
- Patients with Zubrod performance status 0-2.
- Adequate hematologic function defined as: ANC \>/= 1,500/mm3, platelets \>/= 100,000/mm3, and hemoglobin \>/= 9 g/dL (prior to transfusions); adequate hepatic function defined as: total bilirubin \</= 1.5 mg/dl, SGOT or SGPT \</= 3 x ULN, adequate renal function defined as a serum creatinine level \</= 2.0 mg/dl, alkaline phosphatase \</= 2.5 x ULN, glucose \</= 2 x ULN.
- FEV1 with \>/= 1000 cc.
- Patients with a pleural effusion that is a transudate, cytologically negative and nonbloody are eligible if the radiation oncologists feel the tumor can still be encompassed within a reasonable field of radiotherapy. If a pleural effusion can be seen on the chest computed tomography (CT) but not on chest x-ray (CXR) and is too small to tap, the patient is eligible.
- If patients had exploratory thoracotomy, they must have recovered from the procedure (\</= grade 1 or baseline). Exploratory Thoracotomy and beginning of treatment should be within one month.
- Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months \[i.e., who has had menses at any time in the preceding 24 consecutive months\]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for four weeks after completion of treatment.
- For women of childbearing potential, a urine or blood pregnancy test must be performed within 48 hours prior to the start of protocol treatment.
- Prior induction chemotherapy will be allowed, as is prior target therapy. Patients with progression on an EGFR targeting agent will also be allowed, but stratified between the two arms.
- Patients must sign a study-specific consent form prior to study entry.
You may not qualify if:
- Active pulmonary infection not responsive to conventional antibiotics
- History of interstitial lung disease.
- History of severe chronic obstructive pulmonary disease (COPD) requiring \>/= 3 hospitalizations over the past year.
- Significant history of cardiac disease, i.e., uncontrolled hypertension (i.e. can't reduce blood pressure (BP) below a systolic of 160 or diastolic of 100), unstable angina, uncompensated congestive heart failure, myocardial infarction within the past 2 months, or cardiac ventricular arrhythmias requiring medication.
- Patients with \> grade 3 neuropathy.
- Evidence of life threatening disease resulting in a life expectancy of less than 3 months.
- Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant; women with a positive pregnancy test on enrollment or prior to study drug administration.
- Women of childbearing potential and male participants who are unwilling or unable to use an acceptable method of contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for four weeks after completion of treatment or those who are using a prohibited contraceptive method (methods with unknown efficacy).
- Patients who currently are participating in other clinical trials and/or who have participated in other clinical trials (These patient may be enrolled but radiation must not start within 15 days of any previous experiment therapy).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Genentech, Inc.collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Welsh, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2014
First Posted
January 24, 2014
Study Start
June 1, 2014
Primary Completion
June 1, 2019
Last Updated
April 24, 2014
Record last verified: 2014-04