Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062257
• Other study ID #: CTRG-G15/02
• Secondary ID: CDR0000304669NCI
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2003
• Last updated: May 14, 2013
• Start date: June 2003
• Est. completion date: September 2006

Study information

• Verified date: March 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• irofulven

Locations

Country	Name	City	State
Australia	Sydney Cancer Centre at Royal Prince Alfred Hospital	Sydney	New South Wales
Hong Kong	Prince of Wales Hospital	Shatin, New Territories
Korea, Republic of	Yonsei Cancer Center at Yonsei University Medical Center	Seoul
Singapore	Cancer Institute at National University Hospital	Singapore
Singapore	Johns Hopkins - Singapore	Singapore
Singapore	National Cancer Centre - Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Therapeutics Research Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

Australia,  Hong Kong,  Korea, Republic of,  Singapore,