NCT00003867

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Mar 1999

Typical duration for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

4 years

First QC Date

November 1, 1999

Last Update Submit

September 6, 2018

Conditions

Cancer

Keywords

stage III colon cancerstage IV colon cancerstage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage III gastric cancerstage IV gastric cancerrecurrent gastric cancerstage IIIB breast cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancerstage III rectal cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerstage IV anal cancerrecurrent anal cancerstage II esophageal cancerstage III esophageal cancerstage IV esophageal cancerstage IIIA anal cancerstage IIIB anal cancerrecurrent esophageal cancerregional gastrointestinal carcinoid tumormetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorlocalized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver cancersmall intestine adenocarcinomasmall intestine lymphomasmall intestine leiomyosarcomaunresectable gallbladder cancerrecurrent gallbladder cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine cancerunspecified adult solid tumor, protocol specificnewly diagnosed carcinoma of unknown primarycarcinoma of the appendixrecurrent carcinoma of unknown primarystage IV pancreatic cancer

Interventions

capecitabineDRUG
irinotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

Related Publications (1)

  • Goel 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: 12393999RESULT

MeSH Terms

Conditions

NeoplasmsColonic NeoplasmsBreast NeoplasmsStomach NeoplasmsPancreatic NeoplasmsRectal NeoplasmsAnus NeoplasmsEsophageal NeoplasmsCarcinoma, HepatocellularGallbladder NeoplasmsBile Duct NeoplasmsAppendiceal NeoplasmsNeoplasms, Unknown Primary

Interventions

CapecitabineIrinotecan

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesRectal DiseasesAnus DiseasesHead and Neck NeoplasmsEsophageal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsLiver DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesBile Duct DiseasesCecal NeoplasmsCecal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCamptothecinAlkaloids

Study Officials

  • Sridhar Mani, MD

    Albert Einstein College of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

February 16, 2004

Study Start

March 1, 1999

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

September 10, 2018

Record last verified: 2018-09

Locations

US(1)