Recruiting
Phase 2

Personalized Dosing

Sponsor:

AHS Cancer Control Alberta

Code:

NCT01624051

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

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

Study ID

NCT01624051

Start date

Jul, 2014

Status verified date

Sep, 2014

Completion date

Sep, 2015

Anticipated

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Body Surface Area Dosing

Standard dosing arm based on body surface area

experimental: Lean Body Mass Dosing

Experimental dosing arm based on individual lean body mass

Interventions

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

Cisplatin dosing calculated at the rate of 75 mg/m2

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

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

Primary outcome measure

  • Dose limiting toxicity rates [ Time Frame: Assessed weekly until patients come off study (an expected average of 9 weeks) ]
  • Number of Cycles completed [ Time Frame: Assessed weekly until patients come off study (an expected average of 9 weeks) ]

Central Contacts and Locations

Central contacts

Michael B Sawyer, MD

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

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Principal Investigator:

Michael B Sawyer, MD

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Sep 30, 2014

Last verified

Sep, 2014

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2014-09-30.