Clinical trial · Interventional
Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma
A Phase I Clinical Trial to Investigate the Correlation Between UGT1A1 Genotype and Irinotecan (CPT-11) Pharmacokinetics and Toxicity in Cancer Patients
NCT00003970CI-TRIAL-00009111completedPhase 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)
Phase I trial to study genetic testing and the effectiveness of irinotecan in treating patients who have solid tumors and lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a person's genetic makeup
Conditions
Conditions (59)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AIDS-related Peripheral/Systemic Lymphoma | — | UNRESOLVED | — |
| AIDS-related Primary CNS Lymphoma | AIDS-Related Primary Central Nervous System Lymphoma | ALIAS | 0.90 |
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Intraocular Lymphoma | Primary Intraocular Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Primary Central Nervous System Non-Hodgkin Lymphoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (irinotecan hydrochloride)
- description
- Patients receive irinotecan IV over 90 minutes once every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- Grade 3-4 diarrhea
- timeFrame
- Up to 4 years
- description
- A Cochran-Armitage test for trend will be used to determine whether there is a linear trend in the proportion of patients within each genotype experiencing grade 3-4 diarrhea. Similarly, trend analysis will be performed to determine if there is a linear trend in the proportion of patients within each phenotype experiencing grade 3-4 myelosuppression. Genotype (3 ordered levels) will be modeled as a function of metabolic ratios and biliary index to determine whether these are independent.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven solid tumor or lymphoma * Responded to irinotecan OR no existing curative therapy * No leukemia * Measurable or evaluable disease * Performance status - Karnofsky 70-100% * WBC at least 3500/mm\^3 * Absolute neutrophil count at least 1500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin normal * SGOT/SGPT less than 5 times upper limit of normal (unless due to disease) * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception * No inflammatory bowel disease requiring therapy * No chronic diarrhea syndrome or paralytic ileus * At least 2 weeks since prior colony stimulating factor * At least 4 weeks since prior biologic therapy * No concurrent biologic therapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No other concurrent chemotherapy * At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow * No concurrent palliative radiotherapy * No prior transplant * No concurrent substrates of UGT1A1 enzyme * No concurrent inducers or inhibitors of UGT1A1 enzyme activity
References
Publications (0)
Data not yet available
No reference posted for this study.