Development

About paclitaxel poliglumex

Paclitaxel poliglumex is an investigational, biologically enhanced chemotherapeutic agent that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, resulting in a new chemical entity. When bound to the polymer, paclitaxel is inactive, potentially sparing normal tissue’s exposure to high levels of paclitaxel and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to macromolecules such as paclitaxel poliglumex. Based on preclinical studies, it appears that paclitaxel poliglumex is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed, allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing active paclitaxel. Unlike standard radiosensitizing agents, paclitaxel poliglumex appears tumor selective and does not appear to enhance radiation toxicity to normal tissues.

Development Status

Paclitaxel poliglumex is being evaluated through cooperative group-sponsored trials and investigator-sponsored trials in the following indications: ovarian, glioblastoma multiforme and head and neck cancers.

Ovarian Cancer GOG-0212
The Gynecologic Oncology Group (GOG) is investigating paclitaxel poliglumex in a randomized, multicenter, open label Phase 3 trial (GOG-0212) of either monthly paclitaxel poliglumex or Taxol® for up to 12 consecutive months compared to surveillance among women with advanced ovarian cancer who have no evidence of disease following first-line platinum-taxane based therapy.

Paclitaxel or Polyglutamate Paclitaxel or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Peritoneal Cancer or Fallopian Tube Cancer (GOG-0212)

This study is ongoing but is not recruiting patients.

Glioblastoma
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
Ongoing.

Head and Neck Cancer
A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer
Now enrolling.

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