Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Whole-Brain Radiation Therapy With or Without Motexafin Gadolinium in Treating Patients With Brain Metastases from Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over NCI, Pharmaceutical / Industry UCLA-0302038 PCI-P-PCYC-0211, NCT00054795

Objectives

1. Compare the safety and efficacy of motexafin gadolinium and whole brain radiotherapy vs whole brain radiotherapy alone in patients with brain metastases secondary to non-small cell lung cancer.
2. Compare the time to neurologic progression or death (with evidence of neurologic progression) in patients treated with these regimens.
3. Compare the time to neurocognitive progression in patients treated with these regimens.
4. Compare the time to loss of functional independence in patients treated with these regimens.
5. Compare the time to all-cause mortality in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Radiologically proven parenchymal brain metastases secondary to histologically confirmed non-small cell lung cancer



• No liver metastases



• No extracranial metastases to more than 1 organ



• No known leptomeningeal metastases or subarachnoid spread of tumor

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Prior chemotherapy allowed
• No concurrent systemic cytotoxic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Prior radiosurgery allowed provided all of the following criteria are met:
  • No more than 1 radiosurgery treatment was given
  • No more than 3 brain metastases were treated
  • New brain metastases have developed since radiosurgery
  • Edges of new metastases are at least 1 cm from the edges of the 50% isodose line from prior radiosurgery
• No prior whole brain radiotherapy (WBRT)
• No planned radiosurgery or radiotherapy boost after completion of study WBRT
  • Salvage radiosurgery or resection for progression is allowed
• No concurrent WBRT (other than 3 Gy x 10 fractions administered on study)
• Other concurrent radiotherapy allowed provided the following criteria are met:
  • Kidneys and liver are excluded from the irradiated volume
  • Radiotherapy is administered at least 2 hours after motexafin gadolinium administration (for patients in arm I)

Surgery

• See Radiotherapy
• No prior total resection of a single brain metastasis
  • Partial resection or completely resected multiple metastases allowed

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 50,000/mm³

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST or ALT no greater than 2 times ULN
• Lactate dehydrogenase no greater than 1.3 times ULN (no greater than 430 IU/L)

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No uncontrolled hypertension

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No known history of HIV infection
• No known history of AIDS
• No known history of porphyria
• No known history of glucose-6-phosphate-dehydrogenase deficiency
• No major illness or psychiatric impairment that would preclude administration or completion of study therapy or interfere with study follow-up

Expected Enrollment

A total of 550 patients (275 per treatment arm) will be accrued for this study.

Outline

This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, Karnofsky performance status (70-80% vs 90-100%), and age (65 and under vs over 65). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive motexafin gadolinium IV over 10-30 minutes followed within 2-5 hours by whole brain radiotherapy (WBRT) on days 1-5 and 8-12 (total of 10 treatments) in the absence of disease progression or unacceptable toxicity.



• Arm II: Patients receive no motexafin gadolinium. Patients undergo WBRT as in arm I.

Patients are followed monthly for 8 months and then every 2 months for survival.

Mehta MP, Gervais R, Chabot P, et al.: Motexafin gadolinium (MGd) combined with prompt whole brain radiation therapy (RT) prolongs time to neurologic progression in non-small cell lung cancer (NSCLC) patients with brain metastases: results of a phase III trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-7014, 2006.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Judith Ford, MD, PhD, Principal investigator		Ph: 310-825-6427; 888-798-0719

Registry Information
Official Title		Randomized Phase III Trial Of Xcytrin (Motexafin Gadolinium) Injection For The Treatment Of Brain Metastases In Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy
Registered in ClinicalTrials.gov		NCT00054795
Date Submitted to PDQ		2003-07-07
Information Last Verified		2005-05-04
NCI Grant/Contract Number		P30-CA16042