Clinical trial NCT00062257: Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer
Official title: A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: recurrent gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-06-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney Cancer Centre at Royal Prince Alfred Hospital
state: New South Wales
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Cancer Center at Yonsei University Medical Center
city: Singapore
country: Singapore
facility: Cancer Institute at National University Hospital
city: Singapore
country: Singapore
facility: Johns Hopkins - Singapore
city: Singapore
country: Singapore
facility: National Cancer Centre - Singapore
Study officials:
affiliation: Prince of Wales Hospital
name: Winnie Yeo
role: STUDY_CHAIR
References: