NCT00005059

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 II trial to study the effectiveness of carboplatin and paclitaxel in treating patients who have metastatic or recurrent unresectable non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started Jan 2000

Typical duration for phase_2 lung-cancer

Geographic Reach
1 country

18 active sites

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

January 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 26, 2004

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

3.5 years

First QC Date

April 6, 2000

Last Update Submit

July 12, 2016

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • response rate

    Up to 5 years

Study Arms (1)

carboplatin + paclitaxel

EXPERIMENTAL

Following completion of the Lubben Social Network Scale and Frailty Questionnaire, patients receive carboplatin IV over 30 minutes and paclitaxel IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses. Patients with complete response receive 2 additional courses of therapy. Patients with partial response or stable disease may receive additional courses of therapy at investigator's discretion. Patients are followed every 3 months for 5 years or until disease progression.

Drug: carboplatinDrug: paclitaxel

Interventions

carboplatinDRUG
carboplatin + paclitaxel
paclitaxelDRUG
carboplatin + paclitaxel

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Stage IV disease OR Recurrent unresectable disease No other conventional curative or significant palliative therapies available Measurable disease At least one lesion a minimum of one dimension in diameter of at least 20 mm No symptomatic and/or untreated CNS metastases PATIENT CHARACTERISTICS: Age: 65 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 3 times upper limit of normal Renal: Creatinine clearance at least 40 mL/min Other: No uncontrolled infection No uncontrolled seizure disorder No uncontrolled diabetes mellitus No other malignancies within the past 3 years except adequately treated basal or squamous cell skin cancer or noninvasive carcinomas PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic or immunotherapy for recurrent or metastatic disease No concurrent biologic therapy Chemotherapy: No prior chemotherapy for recurrent or metastatic disease except as radiosensitizer No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for recurrent or metastatic disease except as adjuvant therapy At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow No concurrent radiotherapy except for CNS therapy Surgery: See Disease Characteristics At least 3 weeks since 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 (18)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Ann Arbor Hematology Oncology

Ypsilanti, Michigan, 48197, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68131, United States

Location

Quain & Ramstad Clinic, P.C.

Bismarck, North Dakota, 58501, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57105-1080, United States

Location

Related Publications (3)

  • Jatoi A, Hillman S, Stella P, Green E, Adjei A, Nair S, Perez E, Amin B, Schild SE, Castillo R, Jett JR; North Central Cancer Treatment Group. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol. 2005 Dec 20;23(36):9113-9. doi: 10.1200/JCO.2005.03.7465.

    PMID: 16361618BACKGROUND

  • Jatoi A, Hillman S, Stella PJ, Mailliard JA, Sloan J, Vanone S, Cannon MW, Kutteh L, Kanard A, Jett JR. Daily activities: exploring their spectrum and prognostic impact in older, chemotherapy-treated lung cancer patients. Support Care Cancer. 2003 Jul;11(7):460-4. doi: 10.1007/s00520-003-0449-5. Epub 2003 Mar 12.

    PMID: 14505160RESULT

  • Jatoi A, Stella PJ, Hillman S, Mailliard JA, Vanone S, Perez EA, Cannon MW, Geyer S, Wiesenfeld M, Jett JR. Weekly carboplatin and paclitaxel in elderly non-small-cell lung cancer patients (>or=65 years of age): a phase II North Central Cancer Treatment Group study. Am J Clin Oncol. 2003 Oct;26(5):441-7. doi: 10.1097/01.coc.0000027460.53907.38.

    PMID: 14528068RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Aminah Jatoi, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2000

First Posted

May 26, 2004

Study Start

January 1, 2000

Primary Completion

July 1, 2003

Study Completion

April 1, 2006

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

US(18)