Clinical trial · Interventional
Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan
Phase I Study Of Capecitabine in Combination With Cisplatin and Irinotecan in Patients With Advanced Malignancies.
NCT00249977CI-TRIAL-00002988completedPhase 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)
1. To determine the safety and feasibility of administering Capecitabine with the combination of Cisplatin and Irinotecan. 2. To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan. 3. To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine in Combination with Cisplatin and Irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the safety/feasibility of Capecitabine with the combination of Cisplatin and Irinotecan. To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan.
- timeFrame
- Progressing disease or unacceptable toxicities
Secondary outcomes (1)
- measure
- To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.
- timeFrame
- disease progression, unacceptable toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients, 18 years of age or older, with incurable advanced cancer for whom there is no effective therapy are eligible. * Patients must have a life expectancy of at least 12 weeks. * Patients must have a Zubrod performance status of 0-2. * Patients must sign an informed consent. * Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,500 or cells/mm3 and platelet count \>100,000/mm3 and absence of a regular red blood cell transfusion requirement. * Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal. Exclusion Criteria: * Patients with symptomatic brain metastases are excluded from this study. * Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception. * Patients may receive no other concurrent chemotherapy or radiation therapy during this trial. * Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial. * Patients whose cancer progressed while receiving 5-FU, cisplatin or irinotecan.
References
Publications (0)
Data not yet available
No reference posted for this study.