Clinical trial · Interventional
Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors
Escalating Irinotecan (CPT-11) Administered 24 Hours Prior To Gemcitabine In Patients With Refractory Solid Tumors
NCT00054288CI-TRIAL-00013427completedPhase 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 combining irinotecan with gemcitabine in treating patients who have refractory 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed advanced solid tumor that is refractory to prior treatment
* Considered incurable with other modalities
* Measurable or evaluable disease
* The following are not considered measurable or evaluable:
* Bone metastases
* Pleural, pericardial, or peritoneal effusions
* Irradiated lesions (unless progression is documented after radiotherapy)
* Metastatic disease that has been followed using serum tumor markers allowed
* No symptomatic brain metastases
* Brain metastases may not be sole site of metastatic disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* At least 12 weeks
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* AST and ALT no greater than 1.5 times normal
* Bilirubin no greater than 1.5 mg/dL
* No clinically apparent jaundice
Renal
* Creatinine no greater than 1.6 mg/dL OR
* Creatinine clearance at least 50 mL/min
Cardiovascular
* Cardiac function normal
* No uncontrolled heart disease
* No myocardial infarction within the past 3 months
* No congestive heart failure
* No unstable or uncontrolled angina
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No active infection requiring systemic therapy
* No uncontrolled seizures
* No uncontrolled diabetes mellitus
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior gemcitabine
* No prior camptothecin compounds
* Prior irinotecan allowed
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 14 days since prior radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* More than 30 days since prior clinical trial participation
* No other concurrent investigational medicationsReferences
Publications (0)
Data not yet available
No reference posted for this study.