Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 as Second- or Later-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer
- Conditions
- Second-or Later Line treatment in patients with advanced Non-Small Cell lung CancerMedDRA version: 5.1Level: LLTClassification code 10061873
- Registration Number
- EUCTR2005-003501-90-DE
- Lead Sponsor
- Pfizer Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
To be eligible for the study, subjects must satisfy all the following criteria:
1. Histologically documented non-small cell lung cancer with metastases (Stage IV or recurrent disease) or locally advanced (Stage IIIB) with malignant pleural effusion.
2. At least 1 prior systemic platinum-based therapy, or alternative appropriate therapy in case of contraindication against platinum-based therapy for metastatic disease (Prior adjuvant therapy for localized disease does not count as a prior therapy for metastatic disease).
3. No expectation of further effects of prior anticancer therapy.
4. At least 1 target lesion, as defined by RECIST, that has not been irradiated. New lesions that have developed in a previously irradiated field may be used as sites of measurable disease assuming all other criteria are met. All target lesions must have a unidimensional diameter of at least 2 cm. (1 cm is acceptable for spiral CT scans if the reconstruction algorithm is 0.5 cm). Baseline measurements/evaluations must be completed within 4 weeks prior to treatment and performed at the participating investigational site.
5. Adequate bone marrow, hepatic, and renal function documented within 14 days prior to treatment as documented by:
• absolute neutrophil count (ANC, calculated as the absolute number of neutrophils and bands) >=1.5 x 1 000 000 000 cells/L
• platelets >=100 x 1 000 000 000 cells /L
• AST and ALT =<2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT =<5.0 x ULN
• total bilirubin =<1.5 x ULN
• serum creatinine =<1.5 x ULN or calculated creatinine clearance >=60 mL/min
• urinary protein <2+ by urine dipstick. If dipstick is >=2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2 g per 24 hours
6. Age >=18 years.
7. ECOG performance status of 0 or 1
8. No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be =<140, and the baseline diastolic blood pressure readings must be =<90. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
9. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to treatment.
10. Written and voluntary informed consent.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects with one or more of the following criteria are ineligible for this study:
1. Central lung lesions involving major blood vessels (arteries or veins). (Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
2. Patients with a history of Grade 2 or worse hemoptysis are not eligible. Patients with a history of Grade 1 hemoptysis within 30 days of entry are not eligible.
3. Patients who are poor candidates for functional imaging studies (poor candidates include patients who cannot suspend breathing for at least 30 seconds, patients whose only lesions are near the vein that will be used for intravenous contrast injection such as the superior vena cava and subclavian vein [this includes lesions near the hilum of both upper lobes and in the superior mediastinum], patients with lesions that are too small or that could be subjected to cardiac motion or major breathing motion, patients with lesions near metallic clips or hardware, and patients who are allergic to the contrast material) (Note: lesions near either the subclavian or axillary veins may be used for imaging provided that the intravenous catheter for contrast injection is placed in the other site, eg, the axillary vein should be used for contrast injection when a lesion near the subclavian vein is imaged).
4. Gastrointestinal abnormalities including:
• inability to take oral medication
• requirement for intravenous alimentation
• prior surgical procedures affecting absorption including gastric resection
• treatment for active peptic ulcer disease in the past 6 months
• active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy.
• malabsorption syndromes.
5. Previous treatment with an anti-angiogenesis agent such as bevacizumab, SU-11248, sorafenib (however, previous treatment with inhibitors of EGFR, such as cetuximab, erlotinib or gefitinib is allowed).
6. Current use or anticipated inability to avoid use of drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, ergot derivatives, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, and delavirdine).
7. Current use or anticipated inability to avoid use of drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampin, and St. John’s wort).
8. Active seizure disorder or uncontrolled brain metastases (to be eligible, brain metastasis must be previously treated, asymptomatic, without growth for at least 1 month, and must not require steroids)
9. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
10. History of a malignancy (other than non-small cell lung cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years
11. Major surgical procedure or any radiation therapy within 4 weeks of treatment.
12. Dementia or significantly altered mental status that would
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method