Featured Clinical Trial:
Non-Small Cell Lung Cancer (product/compound: Pemetrexed, Gemcitabine, Carboplatin, Cisplatin)
ClinicAid Locations: Southern California – Fountain Valley, Corona, Riverside
Status:
Open for enrollment (accepting patients). Please contact us and mention Trial ID NCT01160744.
Condition: Carcinoma, Non-Small-Cell Lung Cancer
Product Name/Compound:Pemetrexed, Carboplatin (AUC 6), Cisplatin, Gemcitabine, Carboplatin (AUC 5)
Full Study Title: An Open-label, Multicenter, Randomized, Phase 2 Study of a Recombinant Human Anti-VEGFR-2 Monoclonal Antibody, 1121B in Combination With Platinum-based Chemotherapy Versus Platinum-based Chemotherapy Alone as First-line Treatment of Patients With Recurrent or Advanced Non-small Cell Lung Cancer (NSCLC)
Study Summary: The purpose of this study is to determine if patients with Stage 4 non-small cell lung cancer have a better outcome when treated with 24 months 1121B in combination with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin then when treated with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin alone.
Eligible Participants:
Inclusion (Eligible):
- Confirmed Non-small Cell Lung Cancer
- Stage IV disease at the time of study entry
- Measurable disease at the time of study entry
- Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (except alopecia).
- Adequate hematologic function, hepatic function, renal function and coagulation function
- If sexually active, must be postmenopausal, surgically sterile, or using effective contraception; And agrees to use adequate contraception during the study period and for up to 6 months after the last dose of study medication.
- Female patients of childbearing potential must have a negative serum pregnancy test.
Exclusion (Not Eligible):
- Tumor wholly or partially contains small cell lung cancer.
- Untreated central nervous system (CNS) metastases, eligible if they are clinically stable with regard to neurologic function, off all steroids after cranial irradiation at least 2 weeks prior or after surgical resection performed at least 4 weeks prior to randomization.
- Concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. A patient with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years.
- Received prior therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the VEGF or VEGFR.
- Receiving concurrent treatment with other anticancer therapy
- Has received previous chemotherapy for Stage IV NSCLC (patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization).
- Has radiologically documented evidence of major blood vessel invasion or encasement by cancer.
- Has undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions).
- Ongoing or active infection
- History of significant neurological or psychiatric disorders
- Experienced clinically relevant coronary artery disease, myocardial infarction within 6 months prior to randomization, uncontrolled congestive heart failure, or symptomatic poorly controlled arrhythmia.
- Poorly-controlled hypertension
- Experienced any serious 3-4 gastrointestinal bleeding within 3 months prior to study entry.
- Receiving chronic daily treatment with aspirin ( > 325 mg/day) or other known inhibitors of platelet function
- Serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization.
- Major surgery within 28 days prior the first dose of study medication, or subcutaneous venous access device placement within 7 days prior to randomization.
- Elective or a planned major surgery
- Pregnant or lactating.
- Any other serious uncontrolled medical disorders or psychological conditions
- Allergy / history of hypersensitivity reaction to any of the treatment components.
- History of drug abuse
Study Phase: Phase II (What are Phases?)
To receive information and updates for this trial:
Please contact us and mention the Trial ID below.
Trial ID (ClinicalTrials.gov): NCT01160744
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