Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer

NCT00003869 | Completed Phase 3 Results

• 5 other identifiers: NCI-2012-02898CDR000006703397-24-51NCCTG-97-24-51U10CA025224
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized phase III trial to determine the effectiveness of carboxyamidotriazole in treating patients who have stage III or stage IV non-small cell lung cancer. Chemotherapeutic agents are modestly effective for the treatment of advanced lung cancer, with rapid tumor relapse and growth even after initial response to therapy. It is not yet known whether carboxyamidotriazole is more effective than no further treatment after standard chemotherapy for non-small cell lung cancer.

Conditions

Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS was defined as the time from randomization to death of any cause. Participants who did not die or were lost to follow-up were censored at the time of last evaluation/follow-up date. Patients were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.

  up to 5 years

Secondary Outcomes (5)

• Participants With Severe Non-hematologic Adverse Events

  every cycle during treatment

• Time to Disease Progression (TTP)

  up to 5 years

• Clinically Significant (10-point) Decrease in UNISCALE Quality of Life (QOL)Assessment From Baseline to Week 8

  Baseline to week 8

• Clinically Significant (10-point) Decrease in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Quality of Life (QOL)Assessment From Baseline to Week 8

  Baseline to week 8

• Number of Patients With a Confirmed Tumor Responses Treated With CAI.

  During Treatment (up to 5 years)

Study Arms (2)

Arm I (CAI)

EXPERIMENTAL

Patients receive oral carboxyamidotriazole daily.

Drug: carboxyamidotriazole; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive oral placebo daily

Other: placebo; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Interventions

carboxyamidotriazole DRUG

Given PO

Also known as: CAI, carboxyamido-triazole, carboxyaminoimidazole

Arm I (CAI)

placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I (CAI); Arm II (placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (CAI); Arm II (placebo)

Eligibility Criteria

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

You may qualify if:

• TRACK I: Histologically or cytologically confirmed NSCLC stage III or IV; disease must be stable or responding after standard chemotherapy (with or without TRT) for a minimum of 3 or a maximum of 6 months
• TRACK I: Not required to have measurable or evaluable disease at study entry
• TRACK I: Must have had one and only one prior chemotherapy regimen for NSCLC (radiosensitizers are allowed)
• TRACK I: =\< 6 weeks from last dose of chemotherapy or TRT
• TRACK I: ECOG PS 0, 1, or 2
• TRACK I: ANC \>= 1500/mm\^3
• TRACK I: PLT \>= 100,000/mm\^3
• TRACK I: HgB \>= 10.0 g/dL
• TRACK I: Total bilirubin =\< 1.5 x UNL
• TRACK I: Alkaline phosphatase =\< 3 x UNL
• TRACK I: AST =\< 3 x UNL
• TRACK I: Creatinine =\< 1.5 x UNL
• TRACK I: Expected survival of at least three months
• TRACK II AT REGISTRATION: Histologically or cytologically confirmed NSCLC stage III or IV
• TRACK II AT REGISTRATION: No prior chemotherapy for NSCLC

You may not qualify if:

• TRACK I: Pregnant, nursing women, females or sexual partners of childbearing potential not using adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.) while on study treatment and for two months after discontinuing study treatment as this regimen may be harmful to a developing fetus or nursing child
• TRACK I: Untreated brain metastases
• TRACK I: Concomitant participation in a phase III lung cancer treatment trial
• TRACK I: Planned concurrent chemotherapy, immunotherapy or radiotherapy
• TRACK II AT RANDOMIZATION: Pregnant, nursing women, females or sexual partners of childbearing potential not using adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.) while on study treatment and for two months after discontinuing study treatment as this regimen may be harmful to a developing fetus or nursing child
• TRACK II AT RANDOMIZATION: Untreated brain metastases
• TRACK II AT RANDOMIZATION: Planned concurrent chemotherapy, immunotherapy, or radiotherapy

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

carboxyamido-triazole

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Edith A. Perez
• Organization: Mayo Clinic

perez.edith@mayo.edu

Study Officials

• Edith Perez

  North Central Cancer Treatment Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: April 1, 1999
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 20, 2014
• Results First Posted: December 22, 2010

Record last verified: 2012-12

Locations

US (1)