Clinical trial · Interventional

Irinotecan and Capecitabine in Treating Patients With Solid Tumors

Phase I Clinical Study of Every Three Week Irinotecan With Oral Capecitabine Given Twice Daily for Two Weeks Out of Three in Patients With Gastrointestinal and Other Solid Malignancies

NCT00003867CI-TRIAL-00034776completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

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 irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.

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
Cancer	Malignant Neoplasm	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
capecitabine	Drug	Capecitabine	ALIAS
irinotecan hydrochloride	Drug	Irinotecan	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS: Histologically confirmed solid tumors, including but not limited to breast, gastrointestinal, and unknown primary cancer that is refractory to standard therapy or for which no standard therapy exists No known bone marrow involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 OR WBC at least 3,500/mm3 AND Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL No known Gilbert's syndrome No other significant hepatic disease requiring medication Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No significant cardiac disease requiring medication Other: Not pregnant or nursing Fertile patients must use effective contraception No other significant medical condition

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior colony stimulating factor and other cytokines active on bone marrow Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) No prior or concurrent irinotecan and fluorouracil therapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Recovered from prior major surgery

References

Publications (1)

RESULTGoel S, Jhawer M, Rajdev L, Hopkins U, Fehn K, Baker C, Chun HG, Makower D, Landau L, Hoffman A, Wadler S, Mani S. Phase I clinical trial of irinotecan with oral capecitabine in patients with gastrointestinal and other solid malignancies. Am J Clin Oncol. 2002 Oct;25(5):528-34. doi: 10.1097/00000421-200210000-00022. PMID 12393999

Registry

Dates and enrollment

Start: Mar 1, 1999
Primary completion: Mar 1, 2003
Completion: Mar 1, 2003
First posted: Feb 16, 2004
Last update posted: Sep 10, 2018
Enrollment: 30 (actual)
Lead sponsor: Montefiore Medical Center OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: stage III colon cancer, stage IV colon cancer, stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage IIIB breast cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV anal cancer, recurrent anal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, stage IIIA anal cancer, stage IIIB anal cancer, recurrent esophageal cancer, regional gastrointestinal carcinoid tumor, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, small intestine adenocarcinoma, small intestine lymphoma, small intestine leiomyosarcoma, unresectable gallbladder cancer, recurrent gallbladder cancer, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, recurrent small intestine cancer, unspecified adult solid tumor, protocol specific, newly diagnosed carcinoma of unknown primary, carcinoma of the appendix, recurrent carcinoma of unknown primary, stage IV pancreatic cancer

Brief summary (as posted)

Conditions (1)

Interventions (2)

Eligibility (as posted)

Publications (1)

Locations by country (1)