Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Metastatic Solid Tumors
A Phase I Trial of LY231514 With Irinotecan Administered Intravenously Every 21 Days in Patients With Metastatic Cancer
NCT00003711CI-TRIAL-00010476completedPhase 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 with pemetrexed disodium and irinotecan in treating patients who have metastatic 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic solid tumors that are refractory to standard therapies or for which no potentially effective therapy exists No leukemia, lymphoma, or multiple myeloma Measurable or evaluable disease No pleural or peritoneal effusions No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin normal AST and ALT no greater than 3 times normal (no greater than 5 times normal if liver involvement present) Albumin at least 2.5 g/dL Renal: Creatinine clearance at least 45 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study No active infection No concurrent serious systemic disorders Body surface area no greater than 3.0 m2 PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior LY231514 or irinotecan No greater than 6 prior courses of a regimen containing an alkylating agent (except low dose cisplatin) No greater than 4 prior courses of a carboplatin-containing regimen No prior mitomycin No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy (except contraceptives or corticosteroids) Radiotherapy: No prior radiotherapy to 25% or more of the bone marrow No prior radiotherapy to the whole pelvis Recovered from any prior radiotherapy No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since any prior investigational agents No concurrent experimental medications No aspirin or other nonsteroidal antiinflammatory agents for 2 days prior, the day of, and 2 days after the dose of LY231514 (5 days prior to LY231514 for long acting agents such as piroxicam)
References
Publications (0)
Data not yet available
No reference posted for this study.