Standard Temodal (Temozolomide) Regimen Versus Standard Regimen Plus Early Postsurgery Temodal for Newly Diagnosed Glioblastoma Multiforme (Study P05572)

NCT00686725 | Completed Phase 4 Results

• 1 other identifier: P05572
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS was defined as the time from randomization to death. OS was calculated by the Kaplan-Meier method.

  Up to 2 years

Secondary Outcomes (8)

• Progression-Free Survival (PFS)

  Up to 2 years

• Objective Tumor Assessment After Surgery: Overall Response

  Up to 2 years

• Relationship Between O6-methylguanine-DNA Methyltransferase (MGMT) Status and Therapy Response: Overall Survival for the MGMT Positive Group

  Up to 2 years

• Relationship Between MGMT Status and Therapy Response: Overall Survival for the MGMT Negative Group

  Up to 2 years

• Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group

  6, 12, & 18 months

Study Arms (2)

Temozolomide + Radiation

ACTIVE COMPARATOR

Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/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/m\^2/day, and may be increased to 200 mg/m\^2/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. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.

Drug: Temozolomide; Radiation: Radiotherapy

Temozolomide alone, then Temozolomide + Radiation

EXPERIMENTAL

Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.

Drug: Temozolomide; Radiation: Radiotherapy

Interventions

Temozolomide DRUG

Also known as: Temodal, Temodar, SCH 052365

Temozolomide + Radiation; Temozolomide alone, then Temozolomide + Radiation

Radiotherapy RADIATION

Also known as: Irradiation, radiation therapy

Temozolomide + Radiation; Temozolomide alone, then Temozolomide + Radiation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (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;

You may not qualify if:

• 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 human immunodeficiency virus (HIV)-positive or acquired immune deficiency syndrome (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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Mao Y, Yao Y, Zhang LW, Lu YC, Chen ZP, Zhang JM, Qi ST, You C, Wang RZ, Yang SY, Zhang X, Wang JS, Chen JX, Yang QY, Shen H, Li ZY, Wang X, Ma WB, Yang XJ, Zhen HN, Zhou LF. Does Early Postsurgical Temozolomide Plus Concomitant Radiochemotherapy Regimen Have Any Benefit in Newly-diagnosed Glioblastoma Patients? A Multi-center, Randomized, Parallel, Open-label, Phase II Clinical Trial. Chin Med J (Engl). 2015 Oct 20;128(20):2751-8. doi: 10.4103/0366-6999.167313.

  PMID: 26481741 RESULT

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Astrocytoma; 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; Therapeutics; Physical Phenomena

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: June 24, 2008
• Primary Completion: September 28, 2011
• Study Completion: September 28, 2011
• Last Updated: June 14, 2017
• Results First Posted: April 4, 2013

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share