Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

NCT00006372 | Completed Phase 1 DMC

• 4 other identifiers: CWRU1Y99P30CA043703CWRU-1Y99NCI-G00-1859
• Study Type: interventional
• Target: 10
• 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 advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

gemcitabine hydrochloride DRUG

Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

pegylated liposomal doxorubicin hydrochloride DRUG

Patients receive doxorubicin HCl liposome IV over 1-2.5 hours on day 1. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

vinorelbine ditartrate DRUG

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor not amenable to curative surgery, radiotherapy, or chemotherapy * No brain metastases or primary brain tumors PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 3,500/mm3 * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin greater than 10 g/dL Hepatic: * Bilirubin no greater than 1.2 mg/dL * AST and/or ALT less than 2.5 times upper limit of normal (ULN) * PT no greater than ULN (anticoagulant independent) Renal: * Creatinine no greater than 1.5 mg/dL AND/OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease * LVEF at least 45% by MUGA or echocardiogram Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior bone marrow or peripheral blood stem cell transplantation following high dose chemotherapy * At least 3 weeks since prior biologic therapy for cancer and recovered * No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: * See Disease Characteristics * See Biologic therapy * No more than 1 prior chemotherapy regimen * No prior vinca alkaloids * Prior anthracycline allowed if total dose no greater than 300 mg/m2 * At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or carmustine) and recovered Endocrine therapy: * At least 3 weeks since prior endocrine therapy for cancer and recovered Radiotherapy: * See Disease Characteristics * No more than 1 prior radiotherapy regimen * At least 4 weeks since prior large field radiotherapy * At least 3 weeks since prior radiotherapy for cancer and recovered Surgery: * Not specified

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5055, United States

Location

MeSH Terms

Interventions

Gemcitabine; Vinorelbine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Beth A. Overmoyer, MD, FACP

  Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 4, 2000
• First Posted: January 27, 2003
• Study Start: February 1, 2000
• Primary Completion: April 1, 2003
• Study Completion: February 1, 2005
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (1)