Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

Sponsor

Cancer Therapeutics Research Group (Other)

Overall Status

Completed

CT.gov ID

NCT00062257

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: irofulven	Phase 2

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer

Study Start Date :

Jun 1, 2003

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed gastric adenocarcinoma
Recurrent or metastatic disease
Adenocarcinoma of the gastroesophageal junction eligible provided the majority of tumor bulk is below the junction
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sydney Cancer Centre at Royal Prince Alfred Hospital	Sydney	New South Wales	Australia	2050
2	Prince of Wales Hospital	Shatin, New Territories		Hong Kong
3	Yonsei Cancer Center at Yonsei University Medical Center	Seoul		Korea, Republic of	120-752
4	Cancer Institute at National University Hospital	Singapore		Singapore	119074
5	Johns Hopkins - Singapore	Singapore		Singapore	119074
6	National Cancer Centre - Singapore	Singapore		Singapore	169610