Clinical trial · Interventional
Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer
Multicenter Phase II Study Evaluating Gemcitabine and Oxaliplatin in the Treatment of Patients Suffering From Metastatic Breast Cancer Who Are Not Candidates For Treatment With Antracyclines and Taxanes
- 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 gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate
Secondary outcomes (4)
- measure
- Clinical benefit
- measure
- Tolerability
- measure
- Progression-free
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed cancer * Metastatic disease * Measurable metastatic disease ≥ 1 cm by spiral CT scan and/or cutaneous lesion ≥ 2 cm * Not a candidate for anthracycline or taxane chemotherapy * No brain metastases PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Life expectancy \> 12 weeks * Neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Alkaline phosphatase \< 5 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN * Creatinine \< 1.5 times ULN OR creatinine clearance \> 30 mL/min * SGOT and SGPT \< 3 times ULN (5 times ULN if liver metastases present) * No pre-existing neuropathy * Not pregnant or nursing * No uncontrolled hypercalcemia * No familial, social, geographical, or psychological condition that would preclude study treatment * No other malignancy that is not considered cured PRIOR CONCURRENT THERAPY: * No prior chemotherapy for metastatic disease, including anthracyclines or taxanes * Prior hormonal therapy allowed
References
Publications (0)
Data not yet available