Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

NCT ID: NCT00062257

Last Updated: 2013-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2006-09-30

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irofulven, use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well irofulven works in treating patients with recurrent or metastatic gastric cancer.

Detailed Description

OBJECTIVES:

• Determine the response rate of patients with recurrent or metastatic gastric cancer treated with irofulven.
• Determine the toxicity profile of this drug in these patients.
• Determine the overall survival of patients treated with this drug.

OUTLINE: This is a non-randomized, open-label, multicenter study.

Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression, unacceptable toxicity, or static disease after 4 courses in the absence of clinical benefit.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 5-9 months.

Conditions

Gastric Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

irofulven

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Measurable disease

• At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• No active disseminated intravascular coagulation

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST/ALT no greater than 2.5 times ULN (5 times ULN for patients with liver metastases)
• Alkaline phosphatase no greater than 5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior allergic reaction attributed to compounds of similar chemical or biological composition to irofulven
• No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
• No other uncontrolled concurrent illness that would preclude study participation
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• Must have central or peripherally inserted central catheter

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa

Chemotherapy

• No prior chemotherapy for recurrent or metastatic disease
• Prior adjuvant or neoadjuvant chemotherapy allowed provided disease relapsed more than 6 months after therapy

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered

Surgery

• Not specified

Other

• No other concurrent investigational or commercial agents or therapies for the malignancy
• No concurrent combination antiretroviral therapy for HIV-positive patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Cancer Therapeutics Research Group

OTHER

Sponsor Role: lead

Principal Investigators

Winnie Yeo

Role: STUDY_CHAIR

Prince of Wales Hospital

Locations

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Prince of Wales Hospital

Shatin, New Territories, , Hong Kong

Cancer Institute at National University Hospital

Singapore, , Singapore

Johns Hopkins - Singapore

Singapore, , Singapore

National Cancer Centre - Singapore

Singapore, , Singapore

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, , South Korea

Countries

Australia; Hong Kong; Singapore; South Korea

Other Identifiers

CDR0000304669

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-6041

Identifier Type: -

Identifier Source: secondary_id

CTRG-G15/02

Identifier Type: -

Identifier Source: org_study_id