CompletedNCT00326599Updated Mar 21, 2017Results posted

Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

A Phase 2 interventional study of carboplatin and cediranib maleate in Lung Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 154 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-21.

Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 101
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving gemcitabine and carboplatin together with AZD2171 may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and carboplatin together with AZD2171 works compared to giving gemcitabine and carboplatin without AZD2171 as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

Assess the objective tumor response rate in patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine hydrochloride, carboplatin, and AZD2171 as first-line therapy.

Secondary

Compare the proportion of patients who are progression-free at 6 months after treatment with gemcitabine hydrochloride and carboplatin with vs without AZD2171.
Compare the duration of response for responding patients treated with these regimens.
Compare the time-to-progression and time-to-treatment failure.
Compare the 1-year overall survival.
Compare the clinical toxicities.
Assess the safety and tolerability of these regimens in these patients.

Tertiary

Collect blood and tumor specimens for future evaluation of pharmacogenetic and proteomic markers of tumor response and toxicity to therapy with these agents.
Bank paraffin-embedded tissue blocks/slides and blood samples for future histochemistry evaluation and DNA extraction.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant therapy (yes vs no) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and oral AZD2171 once daily on days 1-21. Treatment repeats every 21 days for up to 6 courses. Patients achieving stable disease, partial response, or complete response after 6 courses of therapy receive AZD2171 alone as above. Treatment with AZD2171 repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive gemcitabine and carboplatin as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically during study for pharmacologic correlative studies.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study.

Conditions studied

Lung Cancer

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Keywords

recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
squamous cell lung cancer

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 101 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Squamous cell histology allowed
- No mixed histology with small cell component
Stage IIIB (with pleural effusion) or stage IV disease
- Presence of peritoneal or pericardial effusion alone in the absence of cytologic evidence is not allowed
Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
- If the only site of measurable disease was previously irradiated, progressive disease must be evident
Ineligible for bevacizumab therapy
No symptomatic, untreated, or uncontrolled CNS metastases
- CNS metastases treated with whole-brain radiation (WBRT) allowed 4 weeks after completion of WBRT

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Life expectancy ≥ 12 weeks
Absolute neutrophil count ≥ 1,500/mm\^3
Hemoglobin ≥ 9 g/dL
Platelet count ≥ 100,000/mm\^3
Bilirubin ≤ 3 times upper limit of normal (ULN)
ALT and AST ≤ 3 times ULN (5 times ULN if liver involvement)
Alkaline phosphatase ≤ 5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective nonhormonal contraception
No proteinuria ≥ 1+
No uncontrolled blood pressure (BP), defined as systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg in spite of adequate antihypertensive therapy
No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD2171 (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, or small bowel resection)
No seizure disorder
No significant traumatic injury within 4 weeks prior to study entry
No second primary malignancy except any of the following:
- Carcinoma in situ of the cervix
- Nonmelanoma skin cancer
- Prior malignancy diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
- History of low-grade (Gleason score ≤ 6) localized prostate cancer even if diagnosed \< 5 years prior to registration
- Treated stage I breast cancer ≤ 5 years prior to registration
No uncontrolled intercurrent illness, including, but not limited to, any of the following:
- Ongoing or active infection
- Significant pulmonary symptoms at baseline due to disease
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit compliance with study requirements
- Baseline hemoptysis
- Cavitating lesions
No QTc prolongation > 500 msec or other significant ECG abnormality within the past 14 days
No New York Heart Association class III or IV disease

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior chemotherapy for advanced lung cancer
- Neoadjuvant or adjuvant therapy for lung cancer within the past 12 months allowed
More than 12 months since prior immunotherapy and biologic therapy
More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to skeletal metastases)
At least 2 weeks since prior WBRT
No radiotherapy to ≥ 25% of bone marrow
No major surgery (i.e., laparotomy) or open biopsy within 4 weeks prior to study entry (2 weeks for minor surgery)
- Insertion of a vascular access device not considered major or minor surgery
No concurrent combination antiretroviral therapy for HIV-positive patients
No concurrent grapefruit or grapefruit juice during AZD2171 treatment
No concurrent drugs or biologics with proarrhythmic potential
Concurrent palliative radiotherapy to nontarget sites (i.e., painful pre-existing bony metastasis) allowed with AZD2171 (chemotherapy is held until completion of radiotherapy)

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 101 participants (actual)

Study arms

Experimental
Arm I
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and oral AZD2171 once daily on days 1-21. Treatment repeats every 21 days for up to 6 courses. Patients achieving stable disease, partial response, or complete response after 6 courses of therapy receive AZD2171 alone as above. Treatment with AZD2171 repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: carboplatin · Drug: cediranib maleate · Drug: gemcitabine hydrochloride
Active comparator
Arm II
Patients receive gemcitabine and carboplatin as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: carboplatin · Drug: gemcitabine hydrochloride

Interventions

Drugcarboplatin
Given IV
Drugcediranib maleate
Given orally
Druggemcitabine hydrochloride
Given IV

What researchers measure

Primary outcomes

Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)
A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Complete Response (CR): disappearance of all target lesions; * Partial Response (PR) 30% decrease in sum of longest diameter of target lesions
Time frame: Up to 5 years

Secondary outcomes

Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)
Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 6 months
Progression-free Survival (Phase II Patients Only)
Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.
Time frame: Up to 5 years
Time to Treatment Failure (Phase II Patients Only)
Time to treatment failure was defined to be the time from date of registration to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or death from any cause.
Time frame: Up to 15 months
Overall Survival at 1 Year After Randomization (Phase II Patients Only)
Overall survival was defined as the time from study enrollment to the time of death from any cause. A patient is classified as a success if alive at 1 year.
Time frame: 1 year
Overall Survival (Phase II Patients Only)
Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.
Time frame: Up to 5 years
Dose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)
DLT was defined as an adverse event occurring in cycle 1 only, at least possibly attributed to the study treatment and meeting the following criteria: 1) Grade 4 absolute neutrophil count (ANC) \>5 days or of any duration with fever \>38.5 degree Celsius; 2) Grade 4 platelet count; 3) Grade 3 or higher non-hematologic toxicities (for nausea, vomiting or diarrhea, grade 3 toxicities will be DLT if they occur despite maximal use of anti-emetic support or anti-diarrhea agents, respectively); 4) Cediranib dose interruption of \>14 days for drug-related toxicities.
Time frame: Cycle 1 (up to 3 weeks)

Results

Posted Jan 31, 2017

Participant flow

One hundred-and one (101) participants were enrolled between June 15, 2007 and December 5, 2008. Data for this report were frozen on September 13, 2011.

Participant flow — Overall Study
Milestone	Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)	Lead-in Phase: Arm II (Gemcitabine + Carboplatin)	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)
Started	6	3	58	29
Completed	0	2	5	10
Not completed	6	1	53	19
Withdrew: Withdrawal by subject	1	0	5	2
Withdrew: Adverse event	1	0	32	3
Withdrew: Disease progression	3	1	13	11
Withdrew: Alternate treatment	1	0	0	0
Withdrew: Death	0	0	1	2
Withdrew: Other unspecified reason	0	0	2	1

Outcome measures

PrimaryConfirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)

A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Complete Response (CR): disappearance of all target lesions; * Partial Response (PR) 30% decrease in sum of longest diameter of target lesions

Time frame:: Up to 5 years
Reported as:: Number · percentage of participants

Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)
percentage of participants	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)	19 (10 to 31)	20 (8 to 40)

SecondaryProgression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)

Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame:: 6 months
Reported as:: Number · percentage of participants

Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)
percentage of participants	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)
Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)	48 (35 to 62)	38 (21 to 58)

SecondaryProgression-free Survival (Phase II Patients Only)

Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.

Time frame:: Up to 5 years
Reported as:: Median · months

Progression-free Survival (Phase II Patients Only)
months	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)
Progression-free Survival (Phase II Patients Only)	6.3 (4.7 to 7.9)	4.5 (2.6 to 7.2)

SecondaryTime to Treatment Failure (Phase II Patients Only)

Time to treatment failure was defined to be the time from date of registration to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or death from any cause.

Time frame:: Up to 15 months
Reported as:: Median · months

Time to Treatment Failure (Phase II Patients Only)
months	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)
Time to Treatment Failure (Phase II Patients Only)	2.48 (1.94 to 3.25)	2.89 (1.71 to NA)

SecondaryOverall Survival at 1 Year After Randomization (Phase II Patients Only)

Overall survival was defined as the time from study enrollment to the time of death from any cause. A patient is classified as a success if alive at 1 year.

Time frame:: 1 year
Reported as:: Number · percentage of participants

Overall Survival at 1 Year After Randomization (Phase II Patients Only)
percentage of participants	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)
Overall Survival at 1 Year After Randomization (Phase II Patients Only)	48 (34.9 to 60.7)	41 (23.7 to 58.3)

SecondaryOverall Survival (Phase II Patients Only)

Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.

Time frame:: Up to 5 years
Reported as:: Median · months

Overall Survival (Phase II Patients Only)
months	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)
Overall Survival (Phase II Patients Only)	12.0 (7.5 to 20.6)	9.9 (5.4 to 13.7)

SecondaryDose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)

DLT was defined as an adverse event occurring in cycle 1 only, at least possibly attributed to the study treatment and meeting the following criteria: 1) Grade 4 absolute neutrophil count (ANC) \>5 days or of any duration with fever \>38.5 degree Celsius; 2) Grade 4 platelet count; 3) Grade 3 or higher non-hematologic toxicities (for nausea, vomiting or diarrhea, grade 3 toxicities will be DLT if they occur despite maximal use of anti-emetic support or anti-diarrhea agents, respectively); 4) Cediranib dose interruption of \>14 days for drug-related toxicities.

Time frame:: Cycle 1 (up to 3 weeks)
Reported as:: Number · participants

Dose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)
participants	Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)
Dose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)	1

Adverse events

Collected over Up to 15 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)	—	2/6 (33.3%)	6/6 (100%)
Lead-in Phase: Arm II (Gemcitabine + Carboplatin)	—	2/3 (66.7%)	3/3 (100%)
Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	—	39/58 (67.2%)	58/58 (100%)
Phase II: Arm II (Gemcitabine + Carboplatin)	—	8/29 (27.6%)	29/29 (100%)

Most frequent serious events

Showing 10 of 38

Most frequent serious events
Event	Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)	Lead-in Phase: Arm II (Gemcitabine + Carboplatin)	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)
HypothyroidismEndocrine disorders	0/6	2/3	0/58	0/29
Platelet count decreasedInvestigations	1/6	0/3	23/58	3/29
FatigueGeneral disorders	0/6	1/3	2/58	0/29
Leukocyte count decreasedInvestigations	0/6	1/3	11/58	1/29
Neutrophil count decreasedInvestigations	1/6	1/3	16/58	4/29
DiarrheaGastrointestinal disorders	1/6	0/3	2/58	0/29
NauseaGastrointestinal disorders	1/6	0/3	4/58	0/29
Hemorrhage nasalRespiratory, thoracic and mediastinal disorders	0/6	0/3	7/58	2/29
Hemoglobin decreasedBlood and lymphatic system disorders	0/6	0/3	4/58	0/29
DyspneaRespiratory, thoracic and mediastinal disorders	0/6	0/3	4/58	1/29

Most frequent other events

Showing 10 of 87

Most frequent other events
Event	Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)	Lead-in Phase: Arm II (Gemcitabine + Carboplatin)	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)
Hemoglobin decreasedBlood and lymphatic system disorders	6/6	3/3	53/58	27/29
FatigueGeneral disorders	6/6	3/3	55/58	26/29
Leukocyte count decreasedInvestigations	6/6	3/3	50/58	23/29
Neutrophil count decreasedInvestigations	6/6	3/3	45/58	19/29
Platelet count decreasedInvestigations	6/6	3/3	43/58	23/29
HypertensionVascular disorders	4/6	3/3	30/58	4/29
HypothyroidismEndocrine disorders	0/6	2/3	5/58	2/29
DiarrheaGastrointestinal disorders	4/6	1/3	32/58	5/29
NauseaGastrointestinal disorders	2/6	2/3	35/58	15/29
DyspneaRespiratory, thoracic and mediastinal disorders	3/6	2/3	36/58	19/29

Baseline characteristics

All participants who received treatment.

Age, Continuous
Age, Continuous(years)	Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)	Lead-in Phase: Arm II (Gemcitabine + Carboplatin)	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)	Total
Median	65.5 (62 to 75)	74 (64 to 76)	65 (46 to 81)	64 (45 to 82)	64 (45 to 82)

Sex: Female, Male
Sex: Female, Male(Participants)	Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)	Lead-in Phase: Arm II (Gemcitabine + Carboplatin)	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)	Total
Female	4	3	26	12	45
Male	2	0	32	17	51

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)	Lead-in Phase: Arm II (Gemcitabine + Carboplatin)	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	0	3	2	5
White	6	3	55	26	90
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	1	1

Region of Enrollment
Region of Enrollment(participants)	Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)	Lead-in Phase: Arm II (Gemcitabine + Carboplatin)	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)	Total
United States	6	3	58	29	96

Eastern Cooperative Oncology Group (ECOG) Performance Status
Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants)	Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)	Lead-in Phase: Arm II (Gemcitabine + Carboplatin)	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)	Total
0=Asymptomatic and fully active	3	1	33	17	54
1=Symptomatic and fully ambulatory	3	2	25	12	42

Before adjuvant treatment
Before adjuvant treatment(Participants)	Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)	Lead-in Phase: Arm II (Gemcitabine + Carboplatin)	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)	Total
Yes	1	0	2	1	4
No	5	3	56	28	92

Cell type
Cell type(Participants)	Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)	Lead-in Phase: Arm II (Gemcitabine + Carboplatin)	Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)	Phase II: Arm II (Gemcitabine + Carboplatin)	Total
Squamous	0	1	9	8	18
Adenocarcinoma	4	1	22	16	43
All other	2	1	27	5	35

Study locations

154 sites

Mayo Clinic Scottsdale
Scottsdale, Arizona 85259-5499, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida 32224, United States
Rush-Copley Cancer Care Center
Aurora, Illinois 60504, United States
St. Joseph Medical Center
Bloomington, Illinois 61701, United States
Graham Hospital
Canton, Illinois 61520, United States
Memorial Hospital
Carthage, Illinois 62321, United States
Eureka Community Hospital
Eureka, Illinois 61530, United States
Galesburg Clinic, PC
Galesburg, Illinois 61401, United States
Galesburg Cottage Hospital
Galesburg, Illinois 61401, United States
Mason District Hospital
Havana, Illinois 62644, United States
Hopedale Medical Complex
Hopedale, Illinois 61747, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois 60435, United States
McDonough District Hospital
Macomb, Illinois 61455, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois 61265, United States
Moline, Illinois 61265, United States
BroMenn Regional Medical Center
Normal, Illinois 61761, United States
Community Cancer Center
Normal, Illinois 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois 61554, United States
Proctor Hospital
Peoria, Illinois 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois 61637, United States
Illinois Valley Community Hospital
Peru, Illinois 61354, United States
Perry Memorial Hospital
Princeton, Illinois 61356, United States
St. Margaret's Hospital
Spring Valley, Illinois 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois 61801, United States
CCOP - Carle Cancer Center
Urbana, Illinois 61801, United States
Elkhart General Hospital
Elkhart, Indiana 46515, United States
Howard Community Hospital
Kokomo, Indiana 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana 46350, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana 46360, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana 46601, United States
Saint Joseph Regional Medical Center
South Bend, Indiana 46617, United States
South Bend Clinic
South Bend, Indiana 46617, United States
Bettendorf, Iowa 52722, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa 52403, United States
Mercy Capitol Hospital
Des Moines, Iowa 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa 50316, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa 50401, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa 51104, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan 48106, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan 49017, United States
Mecosta County Medical Center
Big Rapids, Michigan 49307, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan 48123-2500, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan 49431, United States
Genesys Hurley Cancer Institute
Flint, Michigan 48503, United States
Hurley Medical Center
Flint, Michigan 48503, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan 49503, United States
CCOP - Grand Rapids
Grand Rapids, Michigan 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan 49503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan 48236, United States
Holland Community Hospital
Holland, Michigan 49423, United States
Dickinson County Healthcare System
Iron Mountain, Michigan 49801, United States
Foote Memorial Hospital
Jackson, Michigan 49201, United States
Sparrow Regional Cancer Center
Lansing, Michigan 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan 48154, United States
Hackley Hospital
Muskegon, Michigan 49442, United States
St. Joseph Mercy Oakland
Pontiac, Michigan 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan 48601, United States
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan 49085, United States
Munson Medical Center
Traverse City, Michigan 49684, United States
St. John Macomb Hospital
Warren, Michigan 48093, United States
Metro Health Hospital
Wyoming, Michigan 49519, United States
MeritCare Bemidji
Bemidji, Minnesota 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota 55433, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota 55805-1983, United States
CCOP - Duluth
Duluth, Minnesota 55805, United States
Miller - Dwan Medical Center
Duluth, Minnesota 55805, United States
Fairview Southdale Hospital
Edina, Minnesota 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota 55350, United States
Meeker County Memorial Hospital
Lichfield, Minnesota 55355, United States
Immanuel St. Joseph's
Mankato, Minnesota 56002, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota 55416, United States
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota 55102, United States
United Hospital
Saint Paul, Minnesota 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota 55379, United States
Regions Hospital Cancer Care Center
St. Paul, Minnesota 55101, United States
Ridgeview Medical Center
Waconia, Minnesota 55387, United States

Showing the first 100 of 154 sites.

References and documents

Publications

van Cruijsen H, Voest EE, van Herpen CM, et al.: Phase I evaluation of AZD2171, a highly potent, selective VEGFR signaling inhibitor, in combination with gefitinib, in patients with advanced tumors. [Abstract] J Clin Oncol 24 (Suppl 18): A-3017, 125s, 2006.
Dy GK, Mandrekar SJ, Nelson GD, Meyers JP, Adjei AA, Ross HJ, Ansari RH, Lyss AP, Stella PJ, Schild SE, Molina JR, Adjei AA. A randomized phase II study of gemcitabine and carboplatin with or without cediranib as first-line therapy in advanced non-small-cell lung cancer: North Central Cancer Treatment Group Study N0528. J Thorac Oncol. 2013 Jan;8(1):79-88. doi: 10.1097/JTO.0b013e318274a85d. PubMed 23232491 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00326599
Lead sponsor: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: May 17, 2006
Start date: Jun 2007
Primary completion: Apr 2009
Completion: Feb 2010
Results posted: Jan 31, 2017
Last update: Mar 21, 2017

Study contacts

Alex A. Adjei, MD, PhD

study chair · Roswell Park Cancer Institute

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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