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[A combination phase I/II study--dose escalation plan].

N Yamamoto1

  • 1Dept. of Internal Medicine IV, Kinki University School of Medicine, 377-2 Ohno-higashi, Oosaka-Sayama 589-8511, Japan.

Gan to Kagaku Ryoho. Cancer & Chemotherapy
|January 6, 2001
PubMed
Summary
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This study reviewed 30 combination chemotherapy reports to understand dose escalation methods. Findings detail starting doses, patient numbers, and escalation strategies used in clinical trials.

Area of Science:

  • Oncology
  • Clinical Pharmacology

Context:

  • Lack of established guidelines for combination chemotherapy dose escalation.
  • Need for systematic review of existing clinical trial methodologies.

Purpose:

  • To analyze and describe dose escalation methods in combination chemotherapy trials.
  • To evaluate starting doses and patient distribution across dose levels.

Summary:

  • Reviewed 30 Journal of Clinical Oncology reports (1997-1999) on two-drug combination chemotherapy without bone marrow transplantation (BMT).
  • Detailed starting doses, patient numbers per dose level, and specific dose escalation techniques employed.

Impact:

  • Provides insights into historical dose escalation practices in clinical oncology.

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  • Informs future guideline development for combination chemotherapy regimens.