Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
Phase I Study of Oxaliplatin in Combination With 5-Fluorouracil and Gemcitabine in Patients With Solid Tumors
NCT00004242CI-TRIAL-00009418completedPhase 1ClinicalTrials.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)
Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or unresectable solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- See detailed description.
- interventionNames
- Drug: fluorouracil
- Drug: gemcitabine hydrochloride
- Drug: oxaliplatin
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or clinically confirmed metastatic or unresectable solid tumor for which no standard curative or palliative therapy exists or is no longer * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin normal * Proven Gilbert's syndrome (UGT1A1 promoter mutation or clinical * documentation of stress bilirubin levels) allowed * AST/ALT no greater than 3 times upper limit of normal Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Pulmonary: * No unexplained respiratory problems (e.g., nonproductive cough, dyspnea, * rales, pulmonary infiltrates, hypoxia, or tachypnea) Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinical evidence of neuropathy * No prior allergy to platinum compounds * No prior allergy to antiemetics appropriate for administration in * conjunction with protocol directed chemotherapy * No other concurrent uncontrolled illness (e.g., active infection) PRIOR CONCURRENT THERAPY: Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and * platinum) and recovered * No more than 1 prior chemotherapy regimen for cancer Radiotherapy: * At least 4 weeks since prior radiotherapy Other: * No concurrent antiretroviral agents (HAART) * No other concurrent investigational agents or commercial therapies
References
Publications (1)
- RESULTBasu S, Goel S, Hochster H, et al.: Phase I and pharmacokinetic (PK) study of oxaliplatin (Ox) with gemcitabine (Gem) and continuous intravenous (CIV) infusion 5-fluorouracil (FU) in patients with advanced solid malignancies. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2132, 2002.