March 2008 Clinical Trial Reports

By Stanton R. Mehr
Published: Monday, Jun 21, 2010
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PHASE III

Central Nervous System Stimulant for Brain Tumors


Brain radiation can have a number of negative effects on patients while treating brain tumors. This includes adversely affected quality of life (QOL) and impairment of neurocognitive function. However, it is difficult to understand whether these effects are not also caused by the cancer itself. Researchers from Wake Forest School of Medicine, Winston–Salem, North Carolina, recently tested a compound that acts as a central nervous system stimulant, to evaluate its effects on QOL and cognitive function in patients with brain cancer who undergo radiation therapy.

The study group comprised 68 subjects with primary or metastatic brain tumors. They were randomly assigned to receive D-threo-methylphenidate hydrochloride (D-MPH) or placebo. The initial dose of D-MPH was 5 mg bid, which was increased by 5 mg bid to a maximum of 15 mg bid. The placebo was given as one pill bid and could be escalated to three pills bid.

Fatigue was the primary outcome measure. The investigators assessed the patients at baseline, at the conclusion of radiation therapy, and four, eight, and 12 weeks after radiation therapy was complete. Patients were evaluated through the use of the Functional Assessment of Cancer Therapy with brain and fatigue (FACIT- F) subscales in addition to the Center for Epidemiologic Studies Scale and Mini-Mental Status Exam.

At baseline, the mean scores for the D-MPH group and the placebo group were not significantly different. However, eight weeks after the brain RT was completed, no difference was still noted in fatigue between the two patient groups.

The quality of life was not improved by using prophylactic D-MPH in patients with brain tumors who are undergoing radiation therapy, the researchers concluded.


Butler JM Jr, Case LD, Atkins J, et al: A phase III, double-blind, placebo-controlled prospective randomized clinical trial of d-threo-methylphenidate HCl in brain tumor patients receiving radiation therapy. Int J Radiat Oncol Biol Phys 2007;69:1496-1501.





Paclitaxel and Carboplatin Treatment for Patients With Lung Cancer

The efficacy and safety of weekly paclitaxel combined with carboplatin given every four weeks has been compared with the standard regimen of paclitaxel and carboplatin every three weeks for treating individuals with advanced non– small-cell lung cancer (NSCLC). This has been examined by researchers from multiple cancer centers from around the United States.

Patients with previously untreated stage IIIB/ IV NSCLC were randomly assigned to receive either paclitaxel 100 mg/m² weekly for three of four weeks with carboplatin 6 mg/mL-min on day 1 of each four-week cycle (arm 1, 223 patients) or paclitaxel 225 mg/m² and carboplatin 6 mg/mL-min on day 1 of each three-week cycle (arm 2, 221 patients). The 444 patients in both treatment groups were eligible, after four cycles of treatment, to continue weekly paclitaxel (70 mg/m², 3 of 4 wk) as maintenance therapy until disease progression or unacceptable toxicity.

Participants in the weekly paclitaxel arm had an objective response rate of 27.6% compared with 19.2% for those in the every-three-week arm. Median time to progression was 18.4 weeks for arm 1 and 16.7 weeks for arm 2, and the median survival was 38.6 weeks and 42.9 weeks, respectively. Grade 3 or 4 anemia was seen more frequently in the weekly treatment arm, but grade 2 or 3 neuropathy and arthralgia were less common. The two groups were similar with regard to other toxicities.

    Weekly vs. Q3wk Paclitaxel in combination

    chemotherapy for non–small cell lung cancer


  Criteria   Weekly

  Treatment
  Every-3-Week

  Treatment
  Object response rate   27.6%   19.2%
  Median time to

  progression
  18.4 wk   16.7 w


The two treatment groups had similar efficacy parameters, the authors noted. However, they added, the weekly treatment arm demonstrated a favorable nonhematologic toxicity profile, and therefore, this should be considered an acceptable alternative to the standard every-three-week therapy for patients with advanced NSCLC.


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