Clinical trial · Interventional
Docetaxel, Oxaliplatin, and Fluorouracil in Treating Patients With Metastatic or Unresectable Stomach Cancer, Gastroesophageal Junction Cancer, or Other Solid Tumor
A Phase I/II Study of Taxotere, Oxaliplatin, and 5- Fluorouracil
- 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 docetaxel, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given with oxaliplatin and fluorouracil and to see how well they work in treating patients with metastatic or unresectable stomach cancer, gastroesophageal junction cancer, or other solid tumor.
Conditions
Conditions (2)
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 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort 1a
- description
- Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
- interventionNames
- Drug: docetaxel
- Drug: fluorouracil
- Drug: oxaliplatin
- type
- EXPERIMENTAL
- label
- Cohort 2a
- description
- Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
- interventionNames
- Drug: docetaxel
- Drug: fluorouracil
- Drug: oxaliplatin
- type
- EXPERIMENTAL
- label
- Cohort 3a
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic or surgically unresectable solid tumor meeting 1 of the following criteria: * Any solid tumor (Phase I) * Adenocarcinoma of the stomach or gastroesophageal junction (Phase II) * Unidimensionally measurable disease by CT scan or MRI * No uncontrolled brain metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8.0 g/dL * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Total bilirubin normal * Meets 1 of the following criteria: * Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times ULN * AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST or ALT normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 3 months after completion of study therapy * No preexisting neuropathy * No concurrent uncontrolled illness or other condition that would preclude study compliance * No history of severe hypersensitivity reaction to docetaxel or to other drugs formulated with polysorbate 80 * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * More than 4 weeks since prior therapy (Phase I) * No prior oxaliplatin or taxanes (Phase I) * More than 4 weeks since prior radiotherapy (Phase I) * No more than two prior therapies for metastatic disease (Phase I) * No prior therapy for metastatic disease (Phase II) * At least 6 months since prior adjuvant therapy (given prior to the occurrence of metastatic disease) (Phase II) * Prior fluorouracil and concurrent radiotherapy for palliation of the primary tumor allowed provided metastatic disease is present outside the radiotherapy field (Phase II) * No prior radiotherapy to ≥ 30% of bone marrow * No other concurrent investigational agents
References
Publications (1)
- DERIVEDRosenberg AJ, Rademaker A, Hochster HS, Ryan T, Hensing T, Shankaran V, Baddi L, Mahalingam D, Mulcahy MF, Benson AB 3rd. Docetaxel, Oxaliplatin, and 5-Fluorouracil (DOF) in Metastatic and Unresectable Gastric/Gastroesophageal Junction Adenocarcinoma: A Phase II Study with Long-Term Follow-Up. Oncologist. 2019 Aug;24(8):1039-e642. doi: 10.1634/theoncologist.2019-0330. Epub 2019 May 28. PMID 31138725