Phase 2 Study of AZD2171 (NSC 732208) in Combination With Pemetrexed in Relapsed Non-Small Cell Lung Cancer (NOS: 10029514)
Overview
- Phase
- Phase 2
- Intervention
- cediranib maleate
- Conditions
- Recurrent Non-small Cell Lung Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the response rate in patients with relapsed non-small cell lung cancer treated with AZD2171 and pemetrexed disodium. SECONDARY OBJECTIVES: I. Assess the progression-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to prior bevacizumab treatment (yes vs no). 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. \[Note: \* The first course is 4 weeks in duration; all subsequent courses are 3 weeks in duration.\] After completion of study treatment, patients are followed at 4 weeks and then periodically thereafter.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
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.
Intervention: cediranib maleate
Arm I
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.
Intervention: pemetrexed disodium
Outcomes
Primary Outcomes
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.
Time Frame: Up to 4 years
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)
Secondary Outcomes
- 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)