Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Recurrent, Refractory, or Metastatic Solid Tumors or Lymphomas
A Phase I Study of Weekly Gemcitabine in Combination With Infusional 5-Fluorouracil and Oral Calcium Leucovorin in Adult Cancer Patients
- 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 gemcitabine, fluorouracil, and leucovorin in treating patients with recurrent, refractory, or metastatic solid tumors or lymphomas.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | ALIAS | 0.90 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of cancer that has failed standard therapy or for which no such therapy exists, including, but not limited to: * Unresectable primary or recurrent solid tumors (e.g., colon, pancreatic, lung, esophageal, or cholangiocarcinoma) * Metastatic disease * Lymphoma with no prior high-dose chemotherapy requiring autologous or allogeneic stem cell rescue * No leukemias * No CNS metastases or primary CNS malignancies * No failure on prior gemcitabine therapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * Transaminases less than 6 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious concurrent medical illness that would preclude study * No active infections requiring IV antibiotics * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * More than 4 weeks since prior immunotherapy and recovered Chemotherapy: * See Disease Characteristics * More than 4 weeks since prior chemotherapy (at least 6 weeks for mitomycin or nitrosoureas) and recovered * At least 3 months since prior suramin * At least 5 weeks since prior eniluracil (8 weeks prior to start of fluorouracil) and recovered Endocrine therapy: * No steroid therapy if utilized for chronic lymphoma therapy * At least 4 weeks since prior steroidal therapy as disease treatment Radiotherapy: * At least 2 weeks since prior radiotherapy to no more than 20% of bone marrow * At least 4 weeks since prior radiotherapy to 21% or more of bone marrow * Recovered from prior radiotherapy Surgery: * Recovered from prior surgery Other: * No concurrent cimetidine
References
Publications (1)
- BACKGROUNDWright MA, Schuler B, Szabo E, Grem JL. Sustained partial response of an intra-abdominal desmoid tumor treated with gemcitabine, 5-fluorouracil and leucovorin. Ann Oncol. 2003 Apr;14(4):659-60. doi: 10.1093/annonc/mdg155. No abstract available. PMID 12649120