Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Phase I Trial of Combination Pegylated Liposomal Doxorubicin (Doxil), Vinorelbine, and Gemcitabine
NCT00006372CI-TRIAL-00003552completedPhase 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)
RATIONALE: 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. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.
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 |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| vinorelbine ditartrate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor not amenable to curative surgery, radiotherapy, or chemotherapy * No brain metastases or primary brain tumors PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 3,500/mm3 * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin greater than 10 g/dL Hepatic: * Bilirubin no greater than 1.2 mg/dL * AST and/or ALT less than 2.5 times upper limit of normal (ULN) * PT no greater than ULN (anticoagulant independent) Renal: * Creatinine no greater than 1.5 mg/dL AND/OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease * LVEF at least 45% by MUGA or echocardiogram Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior bone marrow or peripheral blood stem cell transplantation following high dose chemotherapy * At least 3 weeks since prior biologic therapy for cancer and recovered * No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: * See Disease Characteristics * See Biologic therapy * No more than 1 prior chemotherapy regimen * No prior vinca alkaloids * Prior anthracycline allowed if total dose no greater than 300 mg/m2 * At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or carmustine) and recovered Endocrine therapy: * At least 3 weeks since prior endocrine therapy for cancer and recovered Radiotherapy: * See Disease Characteristics * No more than 1 prior radiotherapy regimen * At least 4 weeks since prior large field radiotherapy * At least 3 weeks since prior radiotherapy for cancer and recovered Surgery: * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.