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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR PACLITAXEL

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505(b)(2) Clinical Trials for Paclitaxel

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00003589 Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 3 1998-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating advanced non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.
New Formulation NCT00046514 ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer Completed Celgene Corporation Phase 2 2001-06-01 The anticancer agent paclitaxel (marketed as Taxol) has shown remarkable activity against metastatic breast cancer. However, the Taxol formulation requires prolonged administration times, and there are safety problems that have been attributed to the solvent rather than the active ingredient, paclitaxel. This is a new formulation of paclitaxel that has been found to have fewer safety problems than Taxol, and may be administered safely at higher doses. This study will investigate the safety and efficacy of this new formulation of paclitaxel given intravenously once a week for three weeks, followed by a rest week. This cycle will be repeated until safety problems or treatment failure require that the patient stop therapy.
New Formulation NCT00046527 Study of ABI-007 and Taxol in Patients With Metastatic Breast Cancer Completed Celgene Corporation Phase 3 2001-06-01 Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against metastatic breast cancer, as well as other cancers. Because the Taxol formulation of paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol, prolonged intravenous administration times are required; and because the solvent has caused hypersensitivity reactions, a premedication schedule is required. ABI-007 is a new anticancer medication containing the same active ingredient as Taxol, paclitaxel, but formulated as a protein-stabilized material that is suspended in salt water and administered intravenously. The time of administration is reduced, the dose of paclitaxel can be higher than is safe for Taxol, and there is no premedication required. This study will determine the efficacy of this new formulation of paclitaxel, as compared to Taxol, for patients with metastatic breast cancer. This is an open label comparative study, so patients will be randomly assigned to receive either the Taxol or ABI-007 forms of paclitaxel, but will know what medication they are receiving. Treatment will be repeated every three weeks unless adverse events or treatment failure require discontinuing study medication.
New Combination NCT00130520 Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer Completed Genentech, Inc. Phase 2 2005-06-01 The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Paclitaxel

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001383 A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833 Completed National Cancer Institute (NCI) Phase 1 1994-03-01 This is a dosage escalation study to estimate the maximum tolerated dose of drug resistance inhibitor PSC 833 given in combination with paclitaxel. Groups of 3 to 6 patients receive continuous-infusion paclitaxel for 5 days and oral PSC 833 for 6-7 days, following paclitaxel on the first course, then beginning 3 days prior to paclitaxel on subsequent courses. Stable and responding patients are re-treated every 21 days, with paclitaxel dose adjusted to maintain an absolute neutrophil count less than 500 for no more than 4 days.
NCT00001384 A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy With G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients Completed National Cancer Institute (NCI) Phase 2 1994-05-01 This is a pilot feasibility trial of AC (Adriamycin, cyclophosphamide) chemotherapy with G-CSF (filgrastim) followed by infusional Taxol (paclitaxel) as adjuvant treatment for patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in duration. After 3 fourteen day cycles of AC with filgrastim, patients will be treated with 3 fourteen day cycles of 96 hour infusional paclitaxel. The goal of this study will be to assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed by infusional paclitaxel in 14 day cycles.
NCT00001387 Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients With Refractory Malignancy Completed National Cancer Institute (NCI) Phase 1 1994-09-01 The objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy.
NCT00001426 A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer Completed National Cancer Institute (NCI) Phase 2 1995-02-01 A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Paclitaxel

Condition Name

Condition Name for Paclitaxel
Intervention Trials
Breast Cancer 370
Ovarian Cancer 217
Lung Cancer 154
Non-Small Cell Lung Cancer 107
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Condition MeSH

Condition MeSH for Paclitaxel
Intervention Trials
Breast Neoplasms 638
Carcinoma, Non-Small-Cell Lung 447
Lung Neoplasms 443
Ovarian Neoplasms 323
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Clinical Trial Locations for Paclitaxel

Trials by Country

Trials by Country for Paclitaxel
Location Trials
Italy 548
Canada 495
Spain 466
Japan 411
China 399
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Trials by US State

Trials by US State for Paclitaxel
Location Trials
California 498
New York 497
Texas 491
Pennsylvania 424
Ohio 415
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Clinical Trial Progress for Paclitaxel

Clinical Trial Phase

Clinical Trial Phase for Paclitaxel
Clinical Trial Phase Trials
Phase 4 38
Phase 3 441
Phase 2/Phase 3 54
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Clinical Trial Status

Clinical Trial Status for Paclitaxel
Clinical Trial Phase Trials
Completed 964
Recruiting 618
Not yet recruiting 328
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Clinical Trial Sponsors for Paclitaxel

Sponsor Name

Sponsor Name for Paclitaxel
Sponsor Trials
National Cancer Institute (NCI) 596
Celgene Corporation 100
Genentech, Inc. 96
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Sponsor Type

Sponsor Type for Paclitaxel
Sponsor Trials
Other 2600
Industry 1406
NIH 609
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