Clinical trial NCT00326599 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: carboplatin, cediranib maleate, gemcitabine hydrochloride
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, COC1=CC2=C(C=C1OCCCN1CCCC1)N=CN=C2OC1=C(F)C2=C(NC(C)=C2)C=C1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
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)