AZD2171 and Pemetrexed Disodium in Treating Patients With Relapsed Non-Small Cell Lung Cancer

NCT00410904 | Completed Phase 2 Results

• 6 other identifiers: NCI-2009-00165CDR00005173162006-0427389P30CA022453U01CA062487
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial is studying how well giving AZD2171 together with pemetrexed disodium works in treating patients with relapsed non-small cell lung cancer. AZD2171 and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. AZD2171 may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving AZD2171 together with pemetrexed disodium may kill more tumor cells.

Conditions

Recurrent Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate (Complete and Partial) 2 Separate Cohorts of Relapsed NSCLC Cohort A: Pts Who Have Received Prior Chemo w/o Ever Having Received Bevacizumab. Cohort B: Pts Who Have Received Prior Bevacizumab.

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0) for target lesions and assessed by MRI or CT: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Overall Response (OR) = CR + PR, the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started)

  Up to 4 years

Secondary Outcomes (2)

• Progression-free Survival

  The duration of time from start of treatment to time of progression, assessed up to 4 years

• Overall Survival

  The time from start of treatment to time of death, assessed up to 4 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral AZD2171 once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Drug: cediranib maleate; Drug: pemetrexed disodium

Interventions

cediranib maleate DRUG

Also known as: AZD2171, Recentin

Arm I

pemetrexed disodium DRUG

Also known as: ALIMTA, LY231514, MTA

Arm I

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed non-small cell lung cancer
• Measurable disease, defined as \>= 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques or \>= 10 mm by spiral CT scan
• Lesions in a previously irradiated area are considered measurable provided there has been an increase of \>= 10 mm since completion of radiotherapy
• Received 1-2 prior regimens, including 1 doublet chemotherapy regimen, AND meets 1 of the following criteria:
• No prior bevacizumab (cohort A)
• Patients with squamous cell carcinoma, treated and controlled brain metastases, or history of hemoptysis allowed
• Received 1-2 prior regimens\*, including 1 doublet chemotherapy regimen, AND meets 1 of the following criteria:
• Previously treated with bevacizumab (cohort B)
• No discontinuation of bevacizumab for uncontrollable hypertension and/or life-threatening bleeding
• Must have disease progression after prior bevacizumab (NOTE: \*Prior adjuvant therapy is considered 1 regimen if disease progression occurred within 1 year of completion of therapy; if a regimen was discontinued within 2 courses for allergic reaction or unacceptable drug-specific toxicity, that regimen dose not count)
• No large pleural effusion or ascites unless drained
• No active brain metastases by brain MRI or CT scan within the past 4 weeks
• Patients with treated, controlled brain metastasis allowed provided they are neurologically stable without seizures within the past 3 weeks
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Absolute neutrophil count \>= 1,500/mm\^3

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

cediranib; Pemetrexed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Limitations and Caveats

Pemetrexed was approved for front line therapy based on the results of a phase III study; it became known that pemetrexed is ineffective in pts.with squamous cell lung ca. It was also challenging to combine VEGF-TKIS with chemo this pt. population.

Results Point of Contact

• Title: Shirish M. Gadgeel, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

gadgeels@karmanos.org

313-576-8753

Study Officials

• Shirish Gadgeel

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 13, 2006
• Study Start: October 1, 2006
• Primary Completion: July 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 13, 2018
• Results First Posted: September 22, 2014

Record last verified: 2018-03

Locations

US (2)