Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Therapeutics Research Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Irofulven

Criteria

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