Clinical trial · Interventional
Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer
A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer
NCT00062257CI-TRIAL-00010320completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irofulven | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.