Phase II Evaluation of Desipramine for the Treatment of Hot Flashes

2007 ◽  
Vol 4 (4) ◽  
pp. 219-224 ◽  
Author(s):  
Debra L. Barton ◽  
Charles L. Loprinzi ◽  
Pamela Atherton ◽  
Jane Raymond ◽  
Tait Shanafelt ◽  
...  
Keyword(s):  
Phase Ii ◽  
Hot Flashes

Phase II Trial of Anastrozole Plus Goserelin in the Treatment of Hormone Receptor–Positive, Metastatic Carcinoma of the Breast in Premenopausal Women

2010 ◽  
Vol 28 (25) ◽  
pp. 3917-3921 ◽  
Author(s):  
Robert. W. Carlson ◽  
Richard Theriault ◽  
Christine M. Schurman ◽  
Edgardo Rivera ◽  
Cathie T. Chung ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Antitumor Activity ◽  
Phase Ii ◽  
Hormone Receptor ◽  
Phase Ii Trial ◽  
Hot Flashes ◽  
Metastatic Breast ◽  
Premenopausal Women ◽  
Hormone Receptor Positive

Purpose To explore the antitumor activity of the aromatase inhibitor, anastrozole, in the treatment of premenopausal women with hormone receptor–positive, metastatic breast cancer who have been rendered functionally postmenopausal with the use of the luteinizing hormone-releasing hormone agonist, goserelin. Patients and Methods Premenopausal women with estrogen and/or progesterone receptor–positive, metastatic or recurrent breast cancer were enrolled in this prospective, single-arm, multicenter phase II trial. Patients were treated with goserelin 3.6 mg subcutaneous monthly and began anastrozole 1-mg daily 21 days after the first injection of goserelin. Patients continued on treatment until disease progression or unacceptable toxicity. Results Thirty-five patients were enrolled of which 32 were evaluable for response and toxicity. Estradiol suppression was assessed, with mean estradiol levels of 18.7 pg/mL at 3 months and 14.8 pg/mL at 6 months. One participant (3.1%) experienced a complete response, 11 (34.4%) experienced partial response, and 11 (34.4%) experienced stable disease for 6 months or longer for a clinical benefit rate of 71.9%. Median time to progression was 8.3 months (range, 2.1 to 63+) and median survival was not been reached (range, 11.1 to 63+). The most common adverse events were fatigue (50%), arthralgias (53%), and hot flashes (59%). There were no grade 4 to 5 toxicities. Conclusion The combination of goserelin plus anastrozole has substantial antitumor activity in the treatment of premenopausal women with hormone receptor–positive metastatic breast cancer.

scholarly journals A pilot phase II trial of magnesium supplements to reduce menopausal hot flashes in breast cancer patients

2011 ◽  
Vol 19 (6) ◽  
pp. 859-863 ◽  
Author(s):  
Haeseong Park ◽  
Gwendolyn L. Parker ◽  
Cecelia H. Boardman ◽  
Monica M. Morris ◽  
Thomas J. Smith
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Hot Flashes ◽  
Breast Cancer Patients ◽  
Pilot Phase

scholarly journals Bupropion for Control of Hot Flashes in Breast Cancer Survivors: A Prospective, Double-Blind, Randomized, Crossover, Pilot Phase II Trial

2013 ◽  
Vol 45 (6) ◽  
pp. 969-979 ◽  
Author(s):  
Geila Ribeiro Nuñez ◽  
Hélio Pinczowski ◽  
Rebecca Zanellato ◽  
Lívia Tateyama ◽  
Fernanda Schindler ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Phase Ii ◽  
Breast Cancer Survivors ◽  
Phase Ii Trial ◽  
Hot Flashes ◽  
Pilot Phase ◽  
Double Blind

Levetiracetam for the treatment of hot flashes: a phase II study

2007 ◽  
Vol 16 (1) ◽  
pp. 75-82 ◽  
Author(s):  
Susan Thompson ◽  
Aditya Bardia ◽  
Angelina Tan ◽  
Debra L. Barton ◽  
Lisa Kottschade ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Hot Flashes

A phase II study of venlafaxine for the treatment of hot flashes in men undergoing androgen deprivation for prostate cancer

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 8148-8148
Author(s):  
A. Shafqat ◽  
M. L. Titzer ◽  
C. J. Sweeney ◽  
R. B. Giesler ◽  
A. Hanna ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Hot Flashes ◽  
Androgen Deprivation

scholarly journals Phase II evaluation of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes

2015 ◽  
Vol 24 (3) ◽  
pp. 1061-1069 ◽  
Author(s):  
Kunal C. Kadakia ◽  
Charles L. Loprinzi ◽  
Pamela J. Atherton ◽  
Kelliann C. Fee-Schroeder ◽  
Amit Sood ◽  
...  
Keyword(s):  
Phase Ii ◽  
Hot Flashes

Bupropion for hot flashes control in breast cancer survivors: A prospective, double-blind, randomized cross-over pilot phase II trial.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 9102-9102
Author(s):  
G. R. Nuñez ◽  
A. Del Giglio ◽  
H. Pinczowski ◽  
R. M. Zanellato ◽  
L. C. Tateyama ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Phase Ii ◽  
Breast Cancer Survivors ◽  
Phase Ii Trial ◽  
Hot Flashes ◽  
Pilot Phase ◽  
Double Blind

Rate of hot flashes in patients with advanced prostate cancer treated with GTx-758.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 129-129
Author(s):  
Evan Y. Yu ◽  
Marc Gittelman ◽  
Thomas E. Keane ◽  
Ronald Tutrone ◽  
Laurence Belkoff ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Phase Ii ◽  
Advanced Prostate Cancer ◽  
Hot Flashes ◽  
Lower Percentage ◽  
Total Testosterone ◽  
Treatment Groups ◽  
Increased Risk ◽  
Venous Thromboembolic Events

129 Background: When androgen deprivation therapy (ADT) for prostate cancer was first developed, life expectancy for men with advanced disease was short and the systemic effects were of limited relevance. GTx-758 is a selective ERα agonist that effects serum total testosterone (T), free T, SHBG and PSA. Herein we compare the effects of GTx-758 and leuprolide on hot flashes, one of the common side effects in men on ADT. Methods: In a Phase II study (G200705), men with advanced prostate cancer (n=159) received 1000 mg or 2000 mg of GTx-758 daily or leuprolide. Utilizing a standardized instrument to measure the frequency and severity of hot flashes, data was compiled at baseline, day 28 and day 90. The number of men experiencing hot flashes were those reporting any in the period between the respective time point and the prior patient visit. All p values describe the comparison of both GTx-758 treatment groups to the leuprolide treated men. Results: At the baseline, there were no significant differences in the number of men reporting hot flashes in any of the treatment groups (p=0.065). The percentage of men who experienced a hot flash while receiving leuprolide increased significantly to 60.4% (p<0.0001) by Day 28 and increased further to 80.9% (p<0.0001) by Day 90. Although some subjects experienced hot flashes while receiving GTx-758, these men were a significantly lower percentage, 18.8 and 5.6% at the 1000 mg and 2000 mg doses of GTx-758 respectively at day 90. As a result of an increased risk of venous thromboembolic events (VTEs) at these higher doses of GTx-758, the trial was stopped prior to its completion and not all of the men on the study reached the 90 day treatment date (99 evaluable). Conclusions: Men with advanced prostate cancer, receiving GTx-758 experienced a greater than 4-fold reduction in their reported hot flashes at day 90. Since hot flashes are a major side effect that impacts the quality of life in men on ADT, the ability to significantly decrease their likelihood would seem to be of great benefit. A Phase II clinical trial utilizing lower doses of GTx-758 (G200712) is currently being performed that will determine if similar effects on serum free testosterone, PSA and hot flashes can be shown with a lower rate of VTEs. Clinical trial information: NCT01326312.

Phase II study of enzalutamide monotherapy with radiation therapy for intermediate risk prostate cancer.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 58-58
Author(s):  
Glenn Bubley ◽  
Irving D. Kaplan ◽  
Lillian Werner ◽  
Rupal Satish Bhatt ◽  
Mary Ellen Taplin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radiation Therapy ◽  
Side Effects ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Hot Flashes ◽  
Cancer Center ◽  
Intermediate Risk ◽  
Risk Prostate Cancer ◽  
Psa Response

58 Background: Castrating androgen deprivation therapy (ADT) is standardly prescribed in combination with radiation therapy (RT) for intermediate or high-risk prostate cancer (PCa). ADT is associated with multiple side effects including weight gain, loss of libido, hot flashes and muscle atrophy. In contrast, enzalutamide monotherapy is associated with much fewer side effects. Methods: At Dana-Farber/ Harvard Cancer Center we performed an open label phase II study of enzalutamide for 6 months as neo- and adjuvant treatment for intermediate risk PCa patients (NCCN criteria) receiving RT. The primary endpoint was the proportion of patients achieving a PSA response of ≤0.2 . This endpoint is predictive of long term PSA response in a similar risk-group of patients treated with RT and ADT. PSA values were obtained at baseline and monthly on 6 cycles of enzalutamide (160mg/day). 79.2 Gy in 44 fractions of IMRT was started between 6 and 10 weeks after the initiation of enzalutamide. Quality of life questionnaires, hormone levels and anthropomorphic measurements were obtained. Results: 45 of 60 evaluable patients had a PSA ≤0.2 at the end of 6 months of enzalutamide. With a sample size of 64 evaluable patients, if the number achieving a PSA level is ≤0.2 is 44 or more, the null hypothesis is rejected with a target error rate of alpha = 0.10. Also 54 of 60 evaluable patients had a PSA of ≤0.5ng/ml. Importantly, less than half of the participants experienced erectile dysfunction or decreased libido and these were predominantly grade I. Less than a quarter of patients reported hot flashes (all grade I). Waist circumference did not change with therapy. The most frequent grade 2 or greater events were hypertension and gynecomastia. Testosterone and free testosterone levels rose significantly on enzalutamide therapy. Conclusions: Enzalutamide monotherapy with RT may be as effective as castrating ADT, and associated with fewer side effects. Larger, randomized trials are needed to further evaluate enzalutamide monotherapy, instead of ADT, to be used in combination with RT. Clinical trial information: NCT0208988.

TBCRC 002: A phase II, randomized, open label trial of preoperative letrozole versus letrozole (LET) in combination with bevacizumab (BEV) in post-menopausal women with newly diagnosed stage II/III breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 527-527
Author(s):  
Andres Forero-Torres ◽  
Hope S. Rugo ◽  
Christos Vaklavas ◽  
Nancy U. Lin ◽  
Lisa A. Carey ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase Ii ◽  
Single Agent ◽  
Objective Response ◽  
Hot Flashes ◽  
Estrogen Therapy ◽  
Stage Ii ◽  
Her2 Breast Cancer ◽  
Anti Vegf ◽  
Post Menopausal

527 Background: A study from UAB Breast SPORE showed that expression of vascular endothelial growth factor (VEGF) in MCF7 breast tumor xenografts imparts tamoxifen resistance, increases tumor growth and metastatic potential. We postulated that anti-VEGF therapy would enhance anti-estrogen therapy. Methods: Randomized 2:1 phase II selection trial of LET (2.5 mg/day) with/without BEV (anti-VEGF monoclonal antibody; 15 mg/kg q3 weeks) for 24 weeks prior to surgery in post-menopausal patients with stage II/III, ER+/HER2- breast cancer. Primary objective was pathologic complete remission (pCR). Secondary objectives included response rates, down-staging, and toxicity. The trial was not powered to compare arms, but sized to estimate pCR rates to a certain precision (SE<5% for combination, SE<2% for single agent). Biopsies of the tumor and circulating tumor cells were collected. Results: 75 patients were randomized; 50 in the combination and 25 in the LET alone arm; 45 and 24 patients underwent surgery, respectively. Median age was 61 and 65 years, respectively. 5 patients in the combination arm had a pCR (11%; CI 1.9-20.1%) (no evidence of invasive cancer) , and 3 a near pCR (7%; 0%-14.5%) (microscopic disease only); thus pCR/near pCR rate 18% (6.8-29.2%). No patient treated with LET alone achieved a pCR/near pCR. The objective response rate was 64.5% in the combination arm and 37.5% in the single agent arm. 45% of the patients in the combination arm attained stage 0/I; 25% in the letrozole alone arm attained stage I, none attained stage 0. Therapy was well tolerated in both arms with no grade 4/5 toxicity. The most common AEs in the letrozole arm were hot flashes, fatigue, arthralgias/stiffness, myalgias, nausea/vomiting, and night sweats; in the combination arm they were hypertension, arthralgias/stiffness, hot flashes, headache, fatigue, proteinuria, dyspnea, rash, and myalgias. Conclusions: Neoadjuvant therapy with LET and BEV was well-tolerated and resulted in increased objective responses and down-staging. “Next-Gen” genomic analysis of the biopsies will allow for a trial with a targeted patient enrolment. Clinical trial information: F061229006.

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