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Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings. Vol 23, No. 16S, Part I of II: 3188

A Pilot Study of Safety and Efficacy of Pandimex with or without Paclitaxel in the Treatment of Advanced Solid Tumors

X. Ouyang, Z. Yu, Z. Chen, F. Xie, W. Fang, Y. Peng, X. Chen, W. Chen, W. Wang, P. Qi, W. Jia

Background: PBD2131 (Pandimex) is a preparation of aglycone saponins obtained from ginseng. The main active molecules in PBD2131 are 20(S)protopanaxadiol(aPPD) and 20(S)protopanaxatriol(aPPT). Both have shown strong anti-cancer effects in various cancer models(G.Liu, et al. AACR 2004). Both compounds induce apoptosis through caspase-dependent and -independent pathways and inhibit p-glycoprotein. This study was to investigate the safety and efficacy of PBD2131 used with or without paclitaxel.

Methods: Twenty-three patients with advenced solid tumors (lung, gastric, breast, and pancreatic), among whom 9 had distant metastasis, and all failed in previous chemotherapies, were randomized into 3 arms: 1) PBD2131 1000 mg i.v. plus paclitaxel 90 mg/m2 i.v. every 3 weeks for 2 cycles; 2) PBD2131 1000 mg i.v. twice weekly plus paclitaxel 60 mg/m2 i.v. once a week for 2 weeks. Repeat the cycle after a 2-week rest; and 3)PBD2131 1000 mg i.v. alone twice weekly for 4 weeks. Repeat the cycle after a 2-week rest. All patients were pre-treated with dexamethasone, diphenhydramine and cimetidine to reduce hypersensitivity. Blood, liver and kidney functions were tested weekly. Toxicity and adverse events were assessed according NCI Common Toxicity Criteria Manual. Tumor responses as shown in image were assessed according to RECIST.

Results: As summarized in the TableI, there were 6 Grade I and 1 Grade II adverse events (AE) observed. Two of the AEs (Grade I) were in the PBD2131 alone arm and 5 were in the PBD2131-paclitaxel combination arms. There were 4 PRs and 13 SDs observed (1 patient was lost to follow-up).

Conclusions: PBD2131 used alone or in combination with paclitaxel appears to be clinically active in advanced and metastatic solid tumors. The regimens are well-tolerated at the doses studied.


Table I

Total Pts

PR

SD

PD

AE I

AE II

PBD2131/paclitaxel 90 mg/m2

7

3

3

1

2

0

PBD2131/paclitaxel 60 mg/m2

5

0

2

3

2

1

PBD2131 alone

10

1

8

1

2

0

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