Randomized Phase III Trial Comparing Single-Agent Paclitaxel Poliglumex (CT-2103, PPX) with Single-Agent Gemcitabine or Vinorelbine for the Treatment of PS 2 Patients with Chemotherapy-Naïve Advanced Non-small Cell Lung Cancer

O’Brien, Mary; Socinski, Mark A.; Popovich, Alexander Y.; Bondarenko, Igor; Tomova, Antoaneta; ̆ı, Borys T. Bilynsky; Hotko, Yevhen; Ganul, V.L.; Kostinsky, Ippolit Y.; Eisenfeld, Amy J.; Sandalic, Larissa; Oldham, Fred B.; Bandstra, B.; Sandler, Alan; Singer, Jack W.

doi:10.1097/jto.0b013e31817c6b68

Cited by 119 publications

(53 citation statements)

References 16 publications

(8 reference statements)

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“…10 The poly(L-glutamic acid)-paclitaxel conjugate (CT-2103) is considered the most advanced polymerpaclitaxel conjugate to date. 4 CT-2103 has been investigated in Phase III trials, but has not been approved as yet by the Food and Drug Administration, [11][12][13] so there is still a need for an efficacious polymer-paclitaxel conjugate for the treatment of cancer.…”

Section: Introductionmentioning

confidence: 99%

Physicochemical properties and biocompatibility of a polymer-paclitaxel conjugate for cancer treatment

Yang¹,

Van²,

Liu³

et al. 2011

IJN

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Background Poly(L-γ-glutamylglutamine) paclitaxel (PGG-PTX) conjugate is a non-diblock polymeric drug nanoparticle intended to improve the therapeutic index of paclitaxel. The purpose of the present study was to elucidate further the physicochemical properties of PGG-PTX in order to proceed with its clinical development. Methods and results PGG-PTX was designed by integration of a hydrophobic paclitaxel conjugate through an added hydrophilic glutamic acid onto poly(L-glutamic acid). The addition of a flexible glutamic linker between PGA and paclitaxel resulted in spontaneous self-assembly of a PGG-PTX conjugate into nanoparticles. The PGG-PTX conjugate was stable as a lyophilized solid form. An in vitro viability experiment showed that PGG-PTX was effective after a longer incubation period, the same trend as Taxol. In vitro studies using NCI-H460 and B16F0 cancer cells demonstrated significantly high cellular uptake after 30 minutes of incubation. The in vivo biocompatibility of PGG-PTX conjugate was evaluated in the NCI-H460 tumor model, the assessment of tissue seemed to be normal after 21 days of treatment. Conclusion These results are encouraging for further development of non-block polymeric paclitaxel nanoparticles for treatment of cancer.

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Section: Introductionmentioning

confidence: 99%

Physicochemical properties and biocompatibility of a polymer-paclitaxel conjugate for cancer treatment

Yang¹,

Van²,

Liu³

et al. 2011

IJN

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“…Phase I evaluations of OPAXIO™ in patients with advanced solid malignancies have revealed MTDs of 233 mg/m 2 (dosed once every 3 weeks) (62), 177 mg/m 2 (dosed once every 2 weeks) (62), and 70 mg/m 2 (dose once weekly) (65), all of which are enhancements over observed MTDs for Taxol® given at the same schedule. While there are indications of antitumor activity in preclinical models and some early clinical studies, more recent singleagent Phase III studies have failed to show an OPAXIO™-induced significance enhancement in the duration of overall survival for patients with non-smallcell lung cancer (66)(67)(68).…”

Section: Nanoparticle/nanoscaled Formulations Of Small Moleculesmentioning

confidence: 97%

Clinical Developments in Nanotechnology for Cancer Therapy

2010

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Nanoparticle approaches to drug delivery for cancer offer exciting and potentially "game-changing" ways to improve patient care and quality of life in numerous ways, such as reducing off-target toxicities by more selectively directing drug molecules to intracellular targets of cancer cells. Here, we focus on technologies being investigated clinically and discuss numerous types of therapeutic molecules that have been incorporated within nanostructured entities such as nanoparticles. The impacts of nanostructured therapeutics on efficacy and safety, including parameters like pharmacokinetics and biodistribution, are described for several drug molecules. Additionally, we discuss recent advances in the understanding of ligand-based targeting of nanoparticles, such as on receptor avidity and selectivity.

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“…Despite very promising data in preclinical and early phase clinical studies, data from several phase III clinical studies showed that PPX is not signifi cantly more effective than standard treatments [ 54 ]. For example, the conjugate did not show any survival benefi t, compared to either gemcitabine or vinorelbine single agent chemotherapeutic, in a randomized phase III trial in patients with advanced non-small cell lung cancer (NSCLC) [ 55 ]. Similarly, no survival benefi t was found when PPX was used as a second line of treatment against NSCLC in a phase III trial on 849 patients, as compared to docetaxel [ 56 ].…”

Section: Drug-polymer Conjugatesmentioning

confidence: 98%

Nanomedicine: The Promise and Challenges in Cancer Chemotherapy

Naguib

Cui

2014

Advances in Experimental Medicine and Biology

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Randomized Phase III Trial Comparing Single-Agent Paclitaxel Poliglumex (CT-2103, PPX) with Single-Agent Gemcitabine or Vinorelbine for the Treatment of PS 2 Patients with Chemotherapy-Naïve Advanced Non-small Cell Lung Cancer

Abstract: Single-agent PPX, dosed at 175 mg/m, is active and well tolerated in PS 2 patients with advanced NSCLC. Patients on PPX required fewer red blood cell transfusions, hematopoietic growth factors, opioid analgesics, and clinic visits than patients receiving gemcitabine or vinorelbine.

Cited by 119 publications

References 16 publications

Physicochemical properties and biocompatibility of a polymer-paclitaxel conjugate for cancer treatment

Physicochemical properties and biocompatibility of a polymer-paclitaxel conjugate for cancer treatment

Clinical Developments in Nanotechnology for Cancer Therapy

Nanomedicine: The Promise and Challenges in Cancer Chemotherapy

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