A phase I study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma.

Abstract

PURPOSE:

To establish the maximum tolerated dose and dose-limiting toxicity of chemoradiation with paclitaxel (PTX) and cisplatin (CDDP) for patients with local symptoms due to unresectable primary advanced or locally recurrent gastric adenocarcinoma located at left-upper abdomen.

METHODS:

Chemotherapy consisted of PTX at escalating doses of 40-80 mg/m(2) per day and CDDP at escalating doses of 20-25 mg/m(2) per day on days 1, 15, and 29. Concurrent radiation was administered up to a dose of 45 Gy for 5 weeks.

RESULTS:

A total of nine patients were enrolled, of which six were into level 1 (PTX 60 mg/m(2) and CDDP 20 mg/m(2)) and three into level -1 (PTX 50 mg/m(2) and CDDP 20 mg/m(2)). At level 1, one patient developed grade 3 fatigue, and the other experienced grade 5 DIC, grade 5 pneumonia, grade 4 thrombocytopenia, grade 3 hyponatremia, and grade 3 esophagitis as dose-limiting toxicities. A palliative effect was observed in eight of nine patients; six of six patients at level 1 and two of three at level -1.

CONCLUSION:

PTX 50 mg/m(2) and CDDP 20 mg/m(2) given biweekly with concurrent radiation therapy of 45 Gy were well tolerated.

• Authors: Takaki Yoshikawa, Akira Tsuburaya, Naoki Hirabayashi, Kazuhiro Yoshida, Naoki Nagata, Yasuhiro Kodera, Naoto Takahashi, Koji Oba, Masayuki Kimura, Satoshi Ishikura, Yumi Miyashita, Junichi Sakamoto
• Journal: Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 64 Issue 6 Pg. 1071-7 (Nov 2009) ISSN: 1432-0843 [Electronic] Germany
• PMID: 19283353 (Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Paclitaxel
• Cisplatin

Topics

• Adenocarcinoma (drug therapy, radiotherapy, therapy)
• Aged
• Cisplatin (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, radiotherapy)
• Paclitaxel (administration & dosage, adverse effects, therapeutic use)
• Palliative Care (methods)
• Radiotherapy (adverse effects)
• Stomach Neoplasms (drug therapy, radiotherapy, therapy)
• Treatment Outcome