Clinical trial · Interventional
Safety Study of Combination Chemotherapy in Patients With Metastatic Solid Tumors or Adenocarcinoma of the Pancreas
Phase I Study to Determine the Safety, Maximum Tolerated Dose, and Efficacy of Biweekly Oxaliplatin (Eloxatin) in Combination With Gemcitabine, Irinotecan, and 5-FU/Leucovorin (G-Flie) in Patients With Metastatic Solid Tumors or Adenocarcinoma of the Exocrine Pancreas
- 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)
The purpose of this trial is to determine the maximum tolerated dose and the dose-limiting toxicity of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine in patients with metastatic solid tumors or adenocarcinoma of the pancreas.
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 |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine; irinotecan; leucovorin; 5-fluorouracil; oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine
Secondary outcomes (1)
- measure
- To document any antitumor activity with biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine administered on this schedule
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of a solid tumor, OR advanced or metastatic disease that is refractory to conventional treatment or for which no standard therapy exists. 2. Age \> 18 years old. 3. A performance status of ≥ 60 on the Karnofsky scale 4. Life expectancy of at least 12 weeks. 5. Patients must give written informed consent as per institutional and federal regulatory requirements. 6. No chemotherapy, immunotherapy or radiotherapy for at least four weeks prior to entry in the study (six weeks for nitrosureas or mitomycin C). Patients may not receive concurrent chemotherapy, immunotherapy or radiotherapy while participating in this study. Patients may not receive concurrent treatment with any other investigational drug while on this protocol. 7. Patients must have measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST). 8. Absolute granulocyte count of \> 1,500/mm3 and a platelet count \> 100,000/mm3. 9. Patients must have adequate liver and renal function defined by a bilirubin of ≤ 2.0 mg/dl, and a creatinine of ≤ 1.5 mg/dl respectively. 10. Patients must be able to stay in the general area for the duration of their treatment on this clinical research study. 11. Men and women who are fertile must use adequate contraception. Premenopausal women must have a negative pregnancy test documented prior to study entry. 12. Patients must be disease-free of prior invasive malignancies for \>= 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. Exclusion Criteria: Individuals excluded from participating in this study are described below. 1. Women who are pregnant or breast-feeding 2. Patients with clinical signs of brain involvement or leptomeningeal disease. 3. Patients with progressive sensory neuropathy or progressive hearing loss or tinnitus. 4. Patients with other serious illness or medical conditions, including but not limited to the following: * congestive heart failure or angina pectoris * previous history of myocardial infarction within 1 year from study entry * uncontrolled hypertension or arrhythmias * active infections * unstable diabetes mellitus
References
Publications (0)
Data not yet available