Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644) (COMPLETED) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00335075

Purpose

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.

Condition	Intervention	Phase
Glioblastoma Astrocytoma	Drug: Temozolomide Drug: Semustine	Phase III

Drug Information available for: Temozolomide Lomustine Semustine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Progression-free survival [ Time Frame: 2 months, 3 months, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Objective response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Scoring of health-related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	151
Study Start Date:	March 2005
Study Completion Date:	February 2006
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Temodal group: Experimental Subjects treated with temozolomide.	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 group: Active Comparator Subjects treated with semustine.	Drug: Semustine Semustine orally once every 28 days at a dose of 150 mg/m2/day.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P03644
Study First Received:	June 6, 2006
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00335075
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Neuroectodermal Tumors
Glioblastoma
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Lomustine
Semustine

Neuroepithelioma
Glioma
Temozolomide
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009