Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	NCI	NCCTG-N00CB NCI-P01-0199, N00CB, NCT00028574

Objectives

1. Determine the effectiveness of gabapentin in managing hot flashes in men with prostate cancer.
2. Determine the response of patients to this drug.
3. Determine the toxicity of this drug in these patients.
4. Determine the quality of life of patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Diagnosis of prostate cancer
• Received or are currently receiving androgen ablation therapy
• Hot flashes for at least 1 month
  • At least 14 times per week and severe enough to require therapeutic intervention

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior antineoplastic chemotherapy
• No concurrent antineoplastic chemotherapy

Endocrine therapy:

• See Disease Characteristics
• At least 4 weeks since prior androgens, estrogens, or progestational agents
• No concurrent androgens, estrogens, or progestational agents
• Concurrent hormonal therapy allowed if on stable dose for at least 4 weeks and plan to continue therapy throughout study

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No prior gabapentin
• No other concurrent treatment for hot flashes
• Concurrent antidepressants allowed if on stable dose for at least 1 month and plan to continue therapy throughout study

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• At least 6 months

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Creatinine < 1.5 times upper limit of normal over the past 2 years

Other:

• No prior allergic or adverse reaction to gabapentin

Expected Enrollment

A total of 220 patients (55 per treatment arm) will be accrued for this study within 1 year.

Outcomes

Hot flash reduction by diary scores at 4 weeks

Toxicity by questionnaires at 4 weeks

Outline

This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to the number of hot flashes per day (2-3 vs 4-9 vs 10 or more) and duration of hot flash symptoms (less than 9 months vs 9 months or more). Patients are randomized to one of four treatment arms.

All patients are observed for 7 days prior to drug administration in order to collect baseline hot flash information.

• Arm I: Patients receive oral gabapentin once daily on days 1-28.
• Arm II: Patients receive oral gabapentin once daily on days 1-7 and twice daily on days 8-28.
• Arm III: Patients receive oral gabapentin once daily on days 1-7, twice daily on days 8-14, and three times daily on days 15-28.
• Arm IV: Patients receive oral placebo on one of three schedules corresponding to arms I-III.

Patients in all arms may continue therapy with gabapentin for an additional 8 weeks.

Quality of life is assessed at baseline, day 28, and at the end of the additional 8 weeks.

Patients are followed at 6, 12, and 24 months.

Loprinzi CL, Dueck AC, Khoyratty BS, et al.: A phase III randomized, double-blind, placebo-controlled trial of gabapentin in the management of hot flashes in men (N00CB). Ann Oncol 20 (3): 542-9, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Debra Barton, RN, PhD, AOCN, FAAN, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men
Trial Start Date		2001-12-14
Registered in ClinicalTrials.gov		NCT00028574
Date Submitted to PDQ		2001-10-23
Information Last Verified		2006-12-07
NCI Grant/Contract Number		CA31946

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