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Chemotherapy Studies that Involve Taxol(Paclitaxel)

Covered here are

  • Taxol
  • Taxol and Epirubicin
  • Taxol, carboplatin vs Mitoxantrone
  • Strontium, Doxorubicin, ketoconazole, Paclitaxel, estramustine.
  • Taxol, Vinorelbine (Pac-Vin)(2007 ASCO Annual Meeting).
  • Taxol, Emcyt, Carboplatin as a ≥ 2nd line chemotherapy following failure of taxotere. See Table 6.

See also Chemotherapy Studies that Involve Taxol(Paclitaxel) in various combinations

Another page to read is taxol with high dose pulsed calcitriol. This page, except for Table 6 doesn't cover 2nd line studies.

Definitions

PR - partial response

Table 1. Taxol (Paclitaxel). 

Ref

Phase, Number of Patients

Paclitaxel

PSA Response Rate >50%

Decline.

 

Median Duration of Response

median survival

(1)

 

43, some prior emcyt use. all metastatic.

Paclitaxel 80mg/m2 over 1 hour. 6 weeks on and 2 weeks off.

 PSA > 50% decline: 36.1%, 13 of 36 patients.

 Objective Response: 5 of 16 patients or 31.2%.

9 stable disease.

 

 PSA: 4.2 months.

 

 

Median survival 12.8 months

(2)

A Frassoldati et al 2001

9, chemo-naive except for 2 with previous emcyt. 100 mg/m2 over 1 hour, 6 consecutive weeks followed by 2 weeks of rest. Dose reduced to 80mg/m2 for grade 2 peripheral neuropathy. PSA Response Rate (≥ 50% decline in PSA was 75%. (a) No modification of radiological findings was observed. Mean response duration was 5.3 months (range 3-8) & one-year actuarial survival was 83%.
(3) Cancer 2000. 18 patients. All chemo-naive. All mHRPC. 150mg/m2 over 1 hour for 6 of 8 weeks. 7 of 18 (39%) patients had Response Rates (≥ 50%. (b) 18 patients had measurable disease: 1 complete response in the lung and 3 partial responses - 1 in liver, 2 in lymph nodes.

-

(1)  Chiappino I, Destefanis P, Addeo A, Galetto A, Cucchiarale G, Munoz F, Zitella A, Ferrando U, Fontana D, Ricardi U, Tizzani A, Bertetto O., Activity of weekly paclitaxel in advanced hormone-refractory prostate cancer, Am J Clin Oncol. 2007 Jun;30(3):234-8.

Toxicities noted are: anemia grade 3, 16%; neutropenia grade 3-4, 12%) and moderate nonhematologic toxicities (thrombosis/embolism 10%; fatigue all grades, 60%).

 

(2) Antonio Frassoldati, et al, Weekly Paclitaxel in Hormone-Refractory Prostate Cancer(HRPC), ASCO Annual Meeting 2001, abstract # 2396.

(a) All but one patient had a PSA decline that reached a nadir between 4th and 8th week. The mean relative PSA reduction was 61%(range 19-96%). Pain improved in 6 of 7 patients who were previously symptomatic and disappeared entirely in 4 patients. Peripheral neuropathy occurred in all patients - grade 2 adverse p/n event occurred in 4 cases (4 of 9). No patient showed an absolute neutrophil count or platelet reduction grade 1.

 

(3) Trivedi C, Redman B, Flaherty LE, Kucuk O, Du W, Heilbrun LK, Hussain M., Weekly 1-hour infusion of paclitaxel. Clinical feasibility and efficacy in patients with hormone-refractory prostate carcinoma, Cancer. 2000 Jul 15;89(2):431-6. Erratum in: Cancer 2000 Sep 15;89(6):1412.

(b) Peripheral neuropathy was the major high grade toxicity with 6 patients (35%) developing grade 3 toxicity.


Table 2. Paclitaxel and Epirubicin.

Ref

Phase, Number of Patients

Paclitaxel and epirubicin

PSA Response Rate >50%

Decline.

 

Median Response Rate

Median time to progression or median survival

(1)

II, 32

Paclitaxel 70mg/m2 and epirubicin 30 mg/m2  every week for three months

57%

 

 -

Median time to PSA progression 5.5 months; disease progression 7.6 months; survival 12.9 months

(1)  Neri B, Cipriani G, Fulignati C, Turrini M, Ponchietti R, Bartoletti R, Della Melina A, Di Cello V, Dominici A, Maleci D, Raugei A, Villari D, Nicita G. Weekly paclitaxel and epirubicin in the treatment of symptomatic hormone-refractory advanced prostate carcinoma: report of a phase II trial. Anticancer Drugs. 2005 Jan;16(1):63-6.

 Table 3. Paclitaxel, Carboplatin vs Mitoxantrone(Novantrone).

Ref

Phase, Number of Patients

Paclitaxel-Carboplatin

Mitoxantrone

PSA

Response Rate

>50%

Median Response Rate

Median time to progression or median survival

 

(1)*

II, 34 total (ongoing study)

Paclitaxel 175 mg/m2 + carboplatin AUC 5 IV on day 1 of every 3 week cycle

 

44% 4 of 9 analyzed patients

 

 

 

(1)

same as above

 

12 mg/m2 on day 1 of 3 week cycle

8.3% 1 of 12 analyzed patients

 

 

 

 (1) Cabrespine, L. Guy, P. Chollet, J. Fleury, F. Gachon, H. Curé, M. Mouret-Reynier, I. Van Praagh, F. Penault-Llorca, J. Bay Phase II study of paclitaxel carboplatin combination versus mitoxantrone in patients with hormone-refractory prostate cancer. Presented at the 2005 Prostate Cancer Symposium, American Society for Clinical Oncology, 2005.

 

         *Study is ongoing.  Quality of life is not different between the two arms.       

           Patients presented higher level of ChroA at includsion have a higher decline

           of PSA.

 Table 4. Strontium, Doxorubicin, ketoconazole, Paclitaxel, estramustine.

Ref

 

 

 

Phase, Number of Patients

Strontium-89 (S) doxorubicin (D), ketoconazole (K),

Paclitaxel(P), estramutine(E)

PSA

Response Rate

>50%

Median Response Rate

Median time to progression or median survival

(1)*

None,25

S 4 mCi on wk 1 day 1, wks 1,3,5 D 20 mg/m2 first day each wk with K 400 mg 3 times a day for 7 days. Wks 2,4,6 P 100 mg/m2 with E 280 mg orally 3 times a day for 7 days. Responders received 4 8 wk. courses, then maintenance daily K.

18 of 20 patients evaluated so far

 -

Progression free survival range from 2 to 25 months

(1)   H. Henary, R. J. Amato Bone-Targeted Therapy for Androgen-Independent Prostate Cancer (AIPCa) Presented at the 2005 Prostate Cancer Symposium, American Society of Clinical Oncology, 2005.  *Enrollment is ongoing.

Table 5. Paclitaxel (Taxol) and Vinorelbine (Pac-Vin)

Ref

Phase, Number of Patients

Paclitaxel

Vinorelbine

PSA

Response Rate

>50%

Measurable Disease Response Rate

Median time to progression or median survival

Sewak et al(1)@, *

30, II

40 mg/m2 (1 hr); days 1 and 8 of 21-day cycle. 20 mg/m2 I-V; days 1 and 8 of 21-day cycle. 20% PSA RR, with 63% achieving Stable Disease 10 patients had measurable disease. PR was 20%; 70% had stable disease. Median overall survival was 9.7 months. Median progression free survival was 5.1 months.

(1)   S. Sewak, S. Kosmider, V. Ganju, A. Woollett, B. Le, E. Yeo, M. Henry, R. Bell, A phase II study of paclitaxel and vinorelbine (Pac-Vin) in hormone-refractory metastatic prostate cancer (HRPC): A final update, Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 15505. Note that pre-clinical models had shown synergy between paclitaxel and vinorelbine.

     @Previous radiotherapy, strontium therapy, 1 line of chemotherapy (17% had 1 prior chemotherapy), and concurrent bisphosphonate therapy were allowed.

     *Grade 3&4 toxicities were: neutropenia 8%, febrile neutropenia 4%, infection 2%, anemia 3%, lethargy 1%, and somnolescence 1%. 1 pt died as a result of neutropenic sepsis. 

 

Table 6. Taxol, Emcyt, Carboplatin as a ≥ 2nd line chemotherapy following failure of taxotere.

This is 1 study TEC as a 2nd line chemotherapy. There might be others that will be added later.

Reference Phase and No. of Patients Taxol (a) Emcyt Carboplatin

(b)

PSA RR(≥50% decline in PSA Measurable Disease RR Median time to progression or median survival
(1) Sella A, Oncology 2009 Pilot study.  15 patients. 80mg/m2 weekly with dexamethasone and cimetidine premedication. 140mg on days -1, 0 and +1 every week. AUC 6 day 1 of a 21 day cycle.

9 pts

(60%), with another 3 pts(20%) with PSA stable disease.

Partial response in 6 pts (40%) Median duration of progression-free survival was 4.0 months (range 1.1-13 mos). Median survival was 14.6 mos. 

(a) I could find no weeks off for this study (e.g., 3 of 4 weeks, 6 of 8 weeks or every other week) so perhaps patients were treated continuously.

(b) A lower dose of carboplatin might provide a protocol with less toxicity. A dose sometimes used for carboplatin is AUC 2-3 or 200mg on a weekly basis (same weeks as Taxol).

(1) Sella A, Yarom N, Zisman A, Kovel S., Paclitaxel, estramustine and carboplatin combination chemotherapy after initial docetaxel-based chemotherapy in castration-resistant prostate cancer., Oncology. 2009;76(6):442-6. Epub 2009 May 5. Department of Oncology, Assaf Harofeh Medical Center, Zerifin, Israel. a_sella@asaf.health.gov.il

Toxicity: fatigue grade 1–2 in 5 (33%) and grade 3 in 2 PTS (13%), neuropathy
grade 2 and grade 4 in 1 patient each (7%), as well as single episodes of edema (grade 3), diarrhea (grade 2),vomiting (grade 1) and rash (grade 2). Myelosuppression
was mild. 1 patient developed neutropenic fever. One patient died due to
brain hemorrhage with prolonged thrombocytopenia, and an additional patient died due to respiratory failure unrelated to the therapy. The latter patient progressed after the first cycle and developed pneumonia 3 weeks after complete recovery of blood counts. Overall, 4 PTS (27%)
withdrew from therapy due to toxicity: 2 PTS with neurotoxicity, a single patient with prolonged thrombocytopenia (that led to the brain hemorrhage) and a single patient with neutropenic fever.

TEC was toxic in patients who had previously received taxotere with approximately one-third of the patients withdrawing from therapy.

Another page with taxol information is taxol with high dose pulsed calcitriol for other doses, schedules of first line TEC.

Author: Barb Minton, 3/16/2005; Updated 18 January 2010,  H. Hansen





 

 
 

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