Paclitaxel
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Paclitaxel: Parameningeal embryonal rhabdomyosarcoma
One-Sentence Summary
Paclitaxel is a taxane chemotherapy drug, originally used to treat ovarian cancer. with 50 clinical trials and 20 publications compiled for this indication, although most trials are Phase 1/2 combination studies in which paclitaxel is a backbone or partner drug.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Parameningeal embryonal rhabdomyosarcoma |
| TxGNN Prediction Score | 0.9973 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, paclitaxel is a taxane that stabilises microtubules and blocks mitotic progression, which leads to apoptosis in rapidly dividing tumour cells. This general description reflects widely known pharmacology and was not drawn from the compiled data.
Its efficacy in ovarian cancer is established, and ovarian and breast cancers are both solid tumours that respond to antimitotic chemotherapy. Reviews in the compiled literature describe paclitaxel and docetaxel as evidence-based components of therapy for advanced breast, lung and ovarian carcinomas. Paclitaxel’s cytotoxic action does not depend on hormone receptor status, which is why it is also used across several breast cancer subtypes.
Caveat: most of the compiled trials are Phase 1/2 combination studies, so the data do not isolate paclitaxel’s own contribution. Phase 3 trials are present, but they mostly test a partner agent or regimen (for example lapatinib, trastuzumab or gemcitabine added to paclitaxel).
Clinical Trial Evidence
Ten of the most relevant trials are listed below, prioritising those graded as most relevant and those with completed Phase 3 designs.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00003539 | Phase 2 | Completed | 50 | Weekly paclitaxel plus trastuzumab in metastatic breast cancer; direct efficacy and safety data |
| NCT00006120 | Phase 2 | Unknown | Not reported | Randomised comparison of two docetaxel or paclitaxel schedules in metastatic breast cancer |
| NCT00006459 | Phase 3 | Completed | Not reported | Gemcitabine plus paclitaxel vs paclitaxel in locally recurrent or metastatic breast cancer |
| NCT00075270 | Phase 3 | Completed | 580 | Oral lapatinib plus paclitaxel vs paclitaxel alone as first-line therapy in advanced or metastatic breast cancer |
| NCT00667251 | Phase 3 | Completed | 652 | Taxane-based chemotherapy with lapatinib vs trastuzumab as first-line therapy in HER2-positive metastatic breast cancer |
| NCT00553358 | Phase 3 | Completed | 455 | Neo-ALTTO: neoadjuvant lapatinib, trastuzumab or both plus paclitaxel in HER2-positive breast cancer |
| NCT01822314 | Phase 3 | Completed | 632 | ETNA: neoadjuvant nab-paclitaxel vs solvent-based paclitaxel, followed by anthracycline regimens, in HER2-negative high-risk breast cancer |
| NCT00513292 | Phase 3 | Completed | 280 | Sequencing of FEC and paclitaxel plus trastuzumab in HER2-positive operable breast cancer |
| NCT00431080 | Phase 3 | Completed | 478 | Dose-dense FE75C followed by docetaxel vs paclitaxel as adjuvant therapy in node-positive breast cancer |
| NCT00002826 | Phase 2 | Completed | 36 | PSC 833 to modulate multidrug resistance to paclitaxel in metastatic breast cancer; small pilot |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 11147586 | 2000 | Clinical study | Cancer | Phase II multicentre trial of doxorubicin plus paclitaxel in metastatic breast carcinoma, assessing efficacy and toxicity |
| 10791395 | 2000 | Review | Lancet | Taxanes are widely accepted evidence-based components of therapy for advanced breast, lung and ovarian cancers; paclitaxel was approved in the USA for adjuvant node-positive breast cancer |
| 9282422 | 1997 | Review | Drug and Therapeutics Bulletin | Review of paclitaxel and docetaxel in breast and ovarian cancer, covering licence extension to metastatic breast cancer |
| 11745249 | 2001 | Clinical study | Cancer | Role of paclitaxel in multimodality treatment of inflammatory breast carcinoma |
| 9296218 | 1997 | Dose-finding study | Annals of Oncology | Maximum tolerated doses of 3-hour paclitaxel infusion with cyclophosphamide in advanced breast cancer |
| 24823476 | 2014 | Translational study | Nature Communications | TEKT4 germline variations are enriched after treatment and linked to breast cancer resistance to paclitaxel |
| 39317691 | 2024 | Preclinical/computational | Chemical Biology & Drug Design | Paclitaxel combinations against breast carcinoma and in vivo biomarker identification |
| 7904376 | 1993 | Review | Seminars in Oncology Nursing | Overview of paclitaxel’s development history and mechanism |
| 20665703 | 2011 | Preclinical | Journal of Cellular Physiology | ZD6474 enhances paclitaxel’s antiproliferative and apoptotic effects in breast carcinoma cells |
| 34848473 | 2021 | Case report | Anticancer Research | Rare matrix-producing triple-negative breast carcinoma; patient-derived xenograft drug response correlated with patient response |
India Market Information
Paclitaxel has 20 valid single-ingredient registrations in India and none are cancelled. All are injectable or infusion products. The approved-indication text is blank in the registration records.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Registration No. 135197 | Mitotax 100mg Injection (Dr Reddy’s Laboratories Ltd) | Vial of 1 ml injection | Not stated in the records |
| Registration No. 27847 | Bevetex 300mg Injection (Sun Pharmaceutical Industries Ltd) | Vial of 1 injection | Not stated in the records |
| Registration No. 223541 | Taxol 300mg Infusion (BMS India Pvt Ltd) | Bottle of 50 ml infusion | Not stated in the records |
| Registration No. 109647 | Intaxel 100mg Injection (Fresenius Kabi India Pvt Ltd) | Vial of 16.67 ml injection | Not stated in the records |
| Registration No. 153839 | Nab Tortaxel 100mg Injection (Torrent Pharmaceuticals Ltd) | Vial of 1 injection | Not stated in the records |
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Conventional cytotoxic (taxane, microtubule stabiliser) |
| Myelosuppression Risk | High. The knowledge graph links paclitaxel with neutropenia, agranulocytosis, thrombocytopenia and anaemia as contraindicated conditions; one compiled trial also tests a myeloprotective agent given with paclitaxel plus carboplatin |
| Emetogenicity Classification | Please refer to the package insert warnings and precautions |
| Monitoring Items | Complete blood count with differential, liver and renal function, and peripheral neuropathy assessment |
| Handling Protection | Must follow cytotoxic drug handling regulations |
Safety Considerations
- Knowledge-graph contraindications (drug-disease links, not label text): neutropenia, agranulocytosis, thrombocytopenia, anaemia, liver disease, kidney disease, peripheral neuropathy, myocardial infarction, sudden cardiac arrest, hypotensive disorder, asthma, diabetes mellitus and diabetic ketoacidosis, psoriasis, hyperbilirubinaemia and Gilbert syndrome, gallbladder disease, anxiety and related disorders.
- Drug interactions: 553 interactions were identified in total. Moderate-level examples include aprepitant, cimetidine, clarithromycin, clotrimazole, dexamethasone, eliglustat, metronomic azoles (miconazole), metronidazole, rolapitant, rosuvastatin, simvastatin, tinidazole and troglitazone. Minor-level examples include ascorbic acid and levofloxacin.
- Adverse events described in the literature: paclitaxel-induced pneumonitis, uveitis, corneal epithelial lesions, taxane-induced peripheral neuropathy and periarticular thenar erythema with onycholysis.
Package insert warnings and contraindications could not be retrieved. Please refer to the package insert for the authoritative safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Paclitaxel is already a long-established part of breast cancer regimens, and the compiled trials include several completed Phase 3 studies and a randomised Phase 2 comparison across subtypes. However, these trials mostly evaluate partner drugs or regimens rather than paclitaxel alone, so the evidence for this specific indication is best graded L2. The other subtype-level indications (estrogen-receptor positive, estrogen-receptor negative and hormone-resistant breast cancer) point the same way.
To proceed, the following is needed:
- Package insert warnings and contraindications from the India regulator (currently missing, and the blocking gap for safety screening)
- Approved-indication text for the India registrations, to confirm whether breast cancer is already on label
- Detailed mechanism of action data from DrugBank
- Paclitaxel-specific head-to-head Phase 3 evidence, or a guideline review confirming its role as the regimen backbone
- A safety monitoring plan covering myelosuppression, neuropathy and hypersensitivity, and review of the drug interaction list against co-medications
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.