Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors

NCT00005791 | Completed Phase 1

• 3 other identifiers: CDR0000067737MSKCC-99065NCI-G00-1743
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 combination chemotherapy in treating patients who have locally advanced or metastatic solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

cisplatin DRUG

fluorouracil DRUG

irinotecan hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed solid tumor malignancy not amenable to curative surgery or chemoradiation No CNS metastases, carcinomatous meningitis, or interstitial pulmonary fibrosis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases) No known Gilbert's disease Renal: Creatinine no greater than 1.5 mg/dL Calcium less than 12.0 mg/dL No symptomatic hypercalcemia Cardiovascular: No unstable angina No New York Heart Association class III or IV cardiac disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active or uncontrolled infection No history of seizure disorder No uncontrolled diabetes mellitus, defined as random blood sugar 250 mg/dL or greater PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior mantle irradiation, hemibody irradiation, or radiation to the pelvis or lumbar spine Surgery: See Disease Characteristics Other: No concurrent phenytoin, phenobarbital, or other antiepileptic medication No concurrent prochlorperazine on day of irinotecan administration No concurrent prophylactic loperamide

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

• Ku GY, O'Reilly EM, Saltz LB, Schrag D, Maki RG, Kelsen DP, Ilson DH. Phase I study of weekly cisplatin, bolus fluorouracil and escalating doses of irinotecan in advanced solid tumors. Cancer Invest. 2009 May;27(4):402-6. doi: 10.1080/07357900802406327.

  PMID: 19219674 RESULT

MeSH Terms

Interventions

Cisplatin; Fluorouracil; Irinotecan

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids

Study Officials

• David H. Ilson, MD, PhD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: February 16, 2004
• Study Start: October 1, 1999
• Primary Completion: July 1, 2002
• Study Completion: December 1, 2009
• Last Updated: December 19, 2013

Record last verified: 2009-12

Locations

US (1)