Clinical trial · Interventional
Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors
Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With Solid Tumors
NCT00004095CI-TRIAL-00027051completedPhase 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 and gemcitabine in treating patients who have unresectable or metastatic solid tumors.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Irinotecan Plus Gemcitabine
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: irinotecan hydrochloride
Primary outcomes (0)
[]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, having received the following maximum number of prior therapies for advanced disease: * Bladder cancer - no more than 1 prior therapy * Breast cancer - no more than 2 prior therapies * Colorectal cancer - no more than 1 prior therapy * Kidney cancer - no prior therapy * Lung cancer - no more than 1 prior therapy * Pancreatic cancer - no prior therapy * Bidimensionally measurable disease outside a previously irradiated field * At least 2 cm x 2 cm * No known bone metastases * CNS involvement allowed if successfully controlled by surgery or radiotherapy and not requiring corticosteroids * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL regardless of liver involvement secondary to tumor * SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) * No known Gilbert's disease Renal: * Creatinine no greater than 1.8 mg/dL * Calcium less than 12.0 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * No congestive heart failure requiring therapy Other: * No active uncontrolled bacterial, viral (including HIV), or invasive fungal infection * No psychiatric disorders that would prevent compliance * No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix * No history of seizures * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent sargramostim (GM-CSF) * No concurrent immunotherapy Chemotherapy: * No prior irinotecan, topotecan, or gemcitabine * Prior adjuvant chemotherapy allowed, if at least 1 year between last dose of adjuvant chemotherapy and recurrence of cancer * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy to less than 30% of bone marrow * No prior whole pelvic radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
References
Publications (1)
- RESULTWisinski KB, Mulcahy MF, Newman S, et al.: A phase I study of irinotecan and gemcitabine in solid tumors. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-140, 2007.