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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00335075
First received: June 6, 2006
Last updated: September 9, 2008
Last verified: September 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: Temodal group
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.
Other Names:
  • Temodal
  • Temodar
  • SCH 052365
Active Comparator: Semustine group
Subjects treated with semustine.
 Drug: Semustine
Semustine orally once every 28 days at a dose of 150 mg/m2/day.
Other Name: Methyl-CCNU

  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

No publications provided

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

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Semustine
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013