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

NCT00335075 | Completed Phase 3

• 1 other identifier: P03644
• Study Type: interventional
• Target: 151
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glioblastoma; Astrocytoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  2 months, 3 months, and 6 months

Secondary Outcomes (3)

• Overall survival

  6 months

• Objective response

  6 months

• Scoring of health-related quality of life

  6 months

Study Arms (2)

Temodal group

EXPERIMENTAL

Subjects treated with temozolomide.

Drug: Temozolomide

Semustine group

ACTIVE COMPARATOR

Subjects treated with semustine.

Drug: Semustine

Interventions

Temozolomide DRUG

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.

Also known as: Temodal, Temodar, SCH 052365

Temodal group

Semustine DRUG

Semustine orally once every 28 days at a dose of 150 mg/m2/day.

Also known as: Methyl-CCNU

Semustine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Glioblastoma; Astrocytoma

Interventions

Temozolomide; Semustine

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lomustine; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 8, 2006
• Study Start: March 2, 2005
• Primary Completion: February 23, 2006
• Study Completion: February 23, 2006
• Last Updated: May 15, 2017

Record last verified: 2017-05