Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644)

Glioblastoma Clinical Trial

Official title:

A Multicenter, Open-Label, Randomized, Active-Controlled Parallel Groups Study Comparing the Efficacy and Safety of Temodal vs Semustine in the Treatment of Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335075
• Other study ID #: P03644
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2006
• Last updated: May 12, 2017
• Start date: March 2, 2005
• Est. completion date: February 23, 2006

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of the study is to evaluate the efficacy and safety of temozolomide compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic astrocytoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: February 23, 2006
• Est. primary completion date: February 23, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prior histologic confirmation of glioblastoma, anaplastic astrocytoma.

• Evidence of tumor progression or recurrence.

• Age >=18 years.

• Karnofsky performance status >=60%.

• Absolute neutrophil count >=1,500/mm^3, platelet count >=100,000/mm^3, hemoglobin >=8g/dL.

• Serum BUN and creatinine <1.5 times upper normal limit of testing laboratory (ULN).

• Total bilirubin and direct bilirubin <1.5 times ULN.

• SGOT, SGPT <3 times ULN; alkaline phosphatase <2 times ULN.

• Life expectancy greater than 3 months.

• Informed consent obtained.

• If palliative radiation is needed, agree to give it prior to initiating chemotherapy with study drug. If palliative radiation is required during treatment with study drug, the patient should be permanently discontinued from further treatment with study drug.

• Women of childbearing potential must use a medically accepted, effective method of contraception.

• Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug.

Exclusion Criteria:

• Chemotherapy (excluding nitrosourea, mitomycin C or vincristine), biologic therapy or immunotherapy within 4 weeks, inclusive, prior to study drug administration.

• Nitrosourea or mitomycin C administration within 6 weeks, inclusive, prior to study drug administration.

• Vincristine within 2 weeks prior to study drug administration.

• Completion of radiation therapy, interstitial brachytherapy or radiosurgery within 4 weeks prior to study drug administration.

• Surgery within 3 weeks, inclusive, prior to study drug administration.

• Acute infection requiring intravenous antibiotics.

• Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).

• Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.

• Known HIV positive or AIDS-related illness.

• Pregnant or nursing women.

• Men who are not advised to use an effective method of contraception.

Related Conditions & MeSH terms

• Astrocytoma
• Glioblastoma

Intervention

Drug:
• Temozolomide
Temozolomide orally for 5 consecutive days (Day 1 through Day 5) every 28 days, at a dose of 150 mg/m2/day for subjects previously treated with chemotherapy, or 200 mg/m2/day for subjects who have not received previous chemotherapy.
• Semustine
Semustine orally once every 28 days at a dose of 150 mg/m2/day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		2 months, 3 months, and 6 months
Secondary	Overall survival		6 months
Secondary	Objective response		6 months
Secondary	Scoring of health-related quality of life		6 months