Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Standard Temodal (Temozolomide) Regimen Versus Standard Regimen Plus Early Postsurgery Temodal for Newly Diagnosed Glioblastoma Multiforme (Study P05572)
This study is currently recruiting participants.
Verified by Schering-Plough, January 2009
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00686725
  Purpose

The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme.


Condition Intervention Phase
Glioblastoma
Drug: Temozolomide
Radiation: Radiotherapy
Phase IV

Drug Information available for: Temozolomide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Clinical Study of Standard TEMODAL® Regimen Versus Standard Regimen Plus Early Post-Surgery TEMODAL® Chemotherapy in Treatment on Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Objective tumor assessment after surgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Relationship between O6-methylguanine-DNA methyltransferase (MGMT) status and therapy response [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm A: Active Comparator
Standard therapy regimen.
Drug: Temozolomide

For Arm 1, standard treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.

For Arm 2, treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for Arm 1.

Radiation: Radiotherapy
Radiotherapy will be administered in combination with temozolomide in both treatment arms. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
Arm B: Experimental
Early postsurgery temozolomide chemotherapy plus standard regimen.
Drug: Temozolomide

For Arm 1, standard treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.

For Arm 2, treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for Arm 1.

Radiation: Radiotherapy
Radiotherapy will be administered in combination with temozolomide in both treatment arms. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Only the patients who meet all these criteria can be enrolled in the study:

  • Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere.
  • Gross total resection or partial resection (imaging) >70%.
  • At least be capable to obtain a tissue sample for MGMT analysis during surgery.
  • Chemo-radiotherapy to be expected from Week 5 (Day 29) after surgery.
  • Age >=18 and <=70 years.
  • ECOG performance status of 0, 1, or 2.
  • Life expectancy >=9 months.
  • Laboratory test values must satisfy the following criteria:

    • absolute neutrophil count >=1.5 x 10^9/L;
    • platelet count >=100 x 10^9/L;
    • hemoglobin >=80 g/L;
    • blood urea nitrogen and creatinine < 1.5 x upper limit of normal value (ULN);
    • total bilirubin and direct bilirubin < 1.5 x ULN;
    • alanine aminotransferase and aspartate aminotransferase < 3 x ULN;
    • alkaline phosphatase < 2 x ULN.
  • Patients must be willing to provide written informed consent.
  • Patients of child-bearing potential (including female subjects and the female partners of male subjects) must use an effective method of contraception.

Exclusion Criteria:

Patients will not be enrolled if any of the following criteria apply:

  • Patient with previous or current malignancies (except melanoma) at other sites, unless disease free for at least 3 years.
  • Patient who received chemotherapy, radiotherapy for study indication, or other medications for antitumor indication prior to surgery.
  • Patient with recurrent or multiple malignant glioma (including gliomatosis cerebri).
  • Patient with metastatic lesions at the subtentorial or outside of calvaria.
  • Patient who received chemotherapy or radiotherapy sensitizers for head or neck tumor.
  • Patient who received radiotherapy at head or neck which leads to radiotherapy domain overlapping.
  • Patient with acute infections requiring intravenous antibiotics.
  • Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
  • Known HIV-positive or AIDS-related illness.
  • Woman who is pregnant or breastfeeding.
  • Patient with a history of hypersensitivity to temozolomide or other analogic alkylating agents.
  • Patient with any other conditions under which investigators think the subject is not suitable for enrolment, such like having known that the subject may not have good compliance.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686725

Contacts
Contact: SP Clinical Trial Registry Call Center 1-888-772-8734

Locations
China
Investigational Site 1 Recruiting
Shanghai, China, 200040
Investigational Site 2 Recruiting
Beijing, China, 100050
Investigational Site 4 Recruiting
Beijing, China, 100730
Investigational Site 10 Recruiting
Guangzhou, China, 510515
Investigational Site 7 Recruiting
Tianjin, China, 300052
Investigational Site 9 Recruiting
Hangzhou, China, 310009
Investigational Site 5 Recruiting
Chengdu, China, 610041
Sponsors and Collaborators
Schering-Plough
  More Information

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P05572
Study First Received: May 27, 2008
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00686725  
Health Authority: China: State Food and Drug Administration

Study placed in the following topic categories:
Neuroectodermal Tumors
Glioblastoma
Glioblastoma multiforme
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Temozolomide
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