A Study Comparing Chemotherapy Dosing Based on Either Standard Body Surface Area or Lean Body Mass in Patients With Advanced Lung Cancer

NCT01624051 | Unknown Phase 2

• 1 other identifier: Sawyer - Lung - CCI
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer patients are highly variable in their body composition, specifically in the proportion of fat and muscle. Some patients tend to gain fat and lose muscle (or lean body mass) at the same time. These patients can develop severe muscle wasting, termed sarcopenia. Patients with sarcopenia have more severe treatment related toxicity requiring delays, dose reductions and stopping of treatment, and have reduced survival. One potential explanation for this is that patients with sarcopenia have a reduced volume of lean body mass into which chemotherapy drugs are distributed, resulting in a higher concentration and greater toxicity. This study will randomize lung cancer patients to either the standard dosing strategy based on body surface area or experimental, personalized dosing based on lean body mass. Based on retrospective findings in this patient population, the investigators expect to find that severe toxicity will be reduced for sarcopenic patients on the personalized dosing arm based on lean body mass.

Conditions

Lung Cancer

Keywords

cisplatin based chemotherapy; non-small cell lung cancer; lean body mass; sarcopenia

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity rates

  Assessed weekly until patients come off study (an expected average of 9 weeks)

• Number of Cycles completed

  Assessed weekly until patients come off study (an expected average of 9 weeks)

Secondary Outcomes (1)

• Survival

  Assessed every 60 days from the date of removal from the trial (an expected average of 9 months)

Study Arms (2)

Body Surface Area Dosing

ACTIVE COMPARATOR

Standard dosing arm based on body surface area

Other: Standard dosing method arm: Cisplatin (chemotherapy) dosing based on body surface area

Lean Body Mass Dosing

EXPERIMENTAL

Experimental dosing arm based on individual lean body mass

Other: Experimental dosing method arm: Cisplatin (chemotherapy) dosing based on individual lean body mass

Interventions

Standard dosing method arm: Cisplatin (chemotherapy) dosing based on body surface area OTHER

Cisplatin dosing calculated at the rate of 75 mg/m2

Body Surface Area Dosing

Experimental dosing method arm: Cisplatin (chemotherapy) dosing based on individual lean body mass OTHER

Cisplatin dosing calculated at the rate of 3.10 mg/kg lean body mass

Lean Body Mass Dosing

Eligibility Criteria

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

You may qualify if:

• Recommendation from treating oncologist to receive a cisplatin based chemotherapy regimen, specifically either cisplatin/vinorelbine or cisplatin/gemcitabine
• \> or = 18 years of age
• Histologically proven diagnosis of non-small cell lung cancer, Stage IIIB or IV
• Adequate renal function: creatinine \< 1.5 mg/dL or \< 132 µmol/L and creatinine clearance of \> 45 mL/min using the Cockcroft-Gault formula
• Adequate hepatic function: bilirubin \< 1.5 mg/dL or \< 25 µmol/L and AST and ALT \< 2 times upper limit of normal, unless there is evidence of liver metastases, in which case \< 5 times upper limit of normal
• Adequate hematological function: absolute neutrophil count (ANC) \> 1.5 x 109/L and platelets \> 100 x 109/L and hemoglobin \> 100 g/L
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
• Negative serum pregnancy test for women of childbearing potential. Women and men of child bearing potential must use effective contraception defined as the simultaneous use of two reliable methods unless abstinence is the chosen method.
• Life expectancy of \> 4 months in the opinion of the treating oncologist
• Prior radiotherapy is allowed (unless \> 25% of bone marrow stores) if this radiation was \> 4 weeks before study entry and patient has fully recovered from toxicity of this treatment
• Willingness to comply with the study protocol
• Ability to give written informed consent with the understanding that it may be withdrawn at any time without prejudice

You may not qualify if:

• Pregnant or lactating women
• Brain metastases (a CT or MRI is not required to rule out brain metastases unless there is clinical suspicion)
• Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix, in situ ductal breast cancer, non-melanoma skin cancer or low grade bladder cancer
• Patients who have had major surgery within three weeks of enrollment without a full recovery
• Prior treatment with any anticancer therapy
• Patients who have tested positive for HIV
• Any significant medical or psychiatric condition that, in the opinion of the investigator, will exclude the patient from the study for compliance or safety reasons

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

Related Publications (5)

• Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6.

  PMID: 18539529 BACKGROUND

• Tan BH, Birdsell LA, Martin L, Baracos VE, Fearon KC. Sarcopenia in an overweight or obese patient is an adverse prognostic factor in pancreatic cancer. Clin Cancer Res. 2009 Nov 15;15(22):6973-9. doi: 10.1158/1078-0432.CCR-09-1525. Epub 2009 Nov 3.

  PMID: 19887488 BACKGROUND

• Prado CM, Baracos VE, McCargar LJ, Mourtzakis M, Mulder KE, Reiman T, Butts CA, Scarfe AG, Sawyer MB. Body composition as an independent determinant of 5-fluorouracil-based chemotherapy toxicity. Clin Cancer Res. 2007 Jun 1;13(11):3264-8. doi: 10.1158/1078-0432.CCR-06-3067.

  PMID: 17545532 BACKGROUND

• Prado CM, Baracos VE, McCargar LJ, Reiman T, Mourtzakis M, Tonkin K, Mackey JR, Koski S, Pituskin E, Sawyer MB. Sarcopenia as a determinant of chemotherapy toxicity and time to tumor progression in metastatic breast cancer patients receiving capecitabine treatment. Clin Cancer Res. 2009 Apr 15;15(8):2920-6. doi: 10.1158/1078-0432.CCR-08-2242. Epub 2009 Apr 7.

  PMID: 19351764 BACKGROUND

• Antoun S, Birdsell L, Sawyer MB, Venner P, Escudier B, Baracos VE. Association of skeletal muscle wasting with treatment with sorafenib in patients with advanced renal cell carcinoma: results from a placebo-controlled study. J Clin Oncol. 2010 Feb 20;28(6):1054-60. doi: 10.1200/JCO.2009.24.9730. Epub 2010 Jan 19.

  PMID: 20085939 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Sarcopenia

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Michael B Sawyer, MD

  Medical Oncologist, Cross Cancer Institute

  PRINCIPAL INVESTIGATOR

• Vickie Baracos, PhD

  Grant Holder, Department of Oncology, University of Alberta

  STUDY CHAIR

Central Study Contacts

Michael B Sawyer, MD

CONTACT

780-432-8248; michael.sawyer@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: June 20, 2012
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

CA (1)