Clinical trial · Interventional
Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
A Randomized, Open-Label, Multicenter Phase III Study Comparing the Efficacy and Safety of a Combination of Intravenous DX-8951f (Exatecan Mesylate) Plus Gemcitabine to Gemcitabine Alone in Patients With Locally Advanced or Metastatic Cancer of the Exocrine Pancreas Who Have Not Received Prior Chemotherapy
- 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. It is not yet known if gemcitabine is more effective with or without exatecan mesylate in treating pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine alone to that of gemcitabine and exatecan mesylate in treating patients who have locally advanced or metastatic pancreatic cancer.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exatecan mesylate | Drug | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas * Locally advanced (unresectable) or metastatic disease * No islet cell tumor, lymphoma, or sarcoma of the pancreas * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 5 times ULN * Albumin at least 2.8 g/dL Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No active congestive heart failure * No uncontrolled angina * No myocardial infarction Other: * No serious infection or life-threatening illness unrelated to tumor * No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No overt psychosis or incompetency that would preclude study * No history of a positive serology for HIV * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior systemic anticancer immunotherapy for pancreatic cancer * No concurrent anticancer immunotherapy or other biologic therapy Chemotherapy: * No prior systemic anticancer chemotherapy for pancreatic cancer * Prior fluorouracil as a radiosensitizer allowed * No prior gemcitabine as a radiosensitizer * No other concurrent anticancer chemotherapy Endocrine therapy: * Concurrent megestrol for appetite stimulation allowed Radiotherapy: * At least 28 days since prior radiotherapy and recovered * No prior radiotherapy to more than 25% of estimated bone marrow reserve * No concurrent anticancer radiotherapy Surgery: * At least 28 days since prior major surgery and recovered * No concurrent surgery for cancer Other: * No prior investigational or other systemic anticancer therapy for pancreatic cancer * No other concurrent investigational drugs
References
Publications (1)
- RESULTAbou-Alfa GK, Letourneau R, Harker G, Modiano M, Hurwitz H, Tchekmedyian NS, Feit K, Ackerman J, De Jager RL, Eckhardt SG, O'Reilly EM. Randomized phase III study of exatecan and gemcitabine compared with gemcitabine alone in untreated advanced pancreatic cancer. J Clin Oncol. 2006 Sep 20;24(27):4441-7. doi: 10.1200/JCO.2006.07.0201. PMID 16983112