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A Phase II Double Blind Randomized Trial Comparing Standard Dosing Based on Body Surface Area Versus Dosing Based on Personalized Lean Body Mass in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Receiving First Line Cisplatin Based Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

A Phase II Double Blind Randomized Trial Comparing Standard Dosing Based on Body Surface Area Versus Dosing Based on Personalized Lean Body Mass in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Receiving First Line Cisplatin Based Chemotherapy


Retrospective findings of NSCLC patients treated with a cisplatin based chemotherapy regimen
show that although all were given cisplatin at the standard rate of 75 mg/m2 according to
lean body mass, when this was expressed in relation to individual lean body mass, there was
a high degree of variation. Incidence of dose limiting toxicity was 41% in patients whose
dose was within + 25% of the median value. However, sarcopenic patients received on average
a 35% higher dose and 80% of these patients experienced severe toxicity requiring dose
reduction or termination of therapy, a clinically unacceptable level. The relatively
muscular subset of patients with higher lean body mass had a reduced level of severe
toxicity compared to those at the median dose. These findings have led to the design of a
study with the goal of reducing high levels of toxicity in sarcopenic patients. If the
expected level of dose limiting toxicity in sarcopenic patients is 80% based on the standard
method of dosing, this could be expected to be reduced to the median value of 41% dose
limiting toxicity by the administration of cisplatin scaled to individual lean body mass.
Hypothesis: Levels of severe toxicity in sarcopenic patients may be reduced to clinically
acceptable levels by cisplatin dosing scaled to 3.1 mg/kg lean body mass compared with
standard dosing of 75 mg/m2 based on body surface area.


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 ┬Ámol/L and creatinine
clearance of > 45 mL/min using the Cockcroft-Gault formula

- Adequate hepatic function: bilirubin < 1.5 mg/dL or < 25 ┬Ámol/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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicity rates

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Michael B Sawyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Oncologist, Cross Cancer Institute

Authority:

Canada: Health Canada

Study ID:

Sawyer - Lung - CCI

NCT ID:

NCT01624051

Start Date:

July 2012

Completion Date:

September 2015

Related Keywords:

  • Lung Cancer
  • cisplatin based chemotherapy
  • non-small cell lung cancer
  • lean body mass
  • sarcopenia
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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