Clinical trial · Interventional
A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma
A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma
NCT00794417CI-TRIAL-00048768terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Carcinoma | Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aflibercept | Drug | Aflibercept | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin
- description
- Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m\^2 and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
- interventionNames
- Drug: Aflibercept
- Drug: Pemetrexed
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin
- description
- Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m\^2) and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
- interventionNames
- Drug: Aflibercept
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmation of cancer by biopsy (tissue sample) * Phase 1: patients with advanced or metastatic disease that have failed conventional therapy * Phase 2: patients with previously untreated NSCLC, excluding squamous cell histology and cavitating lesions * Age ≥18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate renal, liver and bone marrow function. * Negative pregnancy test (serum or urine) in females of childbearing potential within 7 days of the initial dose of aflibercept * Ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures * Institutional Review Board (IRB) approved, signed and dated informed consent form Exclusion Criteria: * Prior treatment with study medications * Untreated, symptomatic, or progressive Central Nervous System cancer and/or spinal cord compression. Patients with treated brain metastases must have been without symptoms for at least 3 months * Surgery up to 4 weeks prior to the initial administration of aflibercept and/or incomplete wound healing * Anti-VEGF therapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only) * Chemotherapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only) * Other investigational treatment up to 4 weeks prior to the initial administration of aflibercept * Any of the following up to 6 months (24 weeks) prior to the initial administration of aflibercept: * Severe cardiovascular disease or event * Cerebrovascular accident, transient ischemic attack, or moderate to severe peripheral neuropathy * Erosive esophagitis or gastritis, infectious or inflammatory bowel disease, and diverticulitis * Deep vein thrombosis, pulmonary embolism, or other clotting event * Episode(s)of moderate to severe, continuous bleeding * Breast-feeding or pregnancy
References
Publications (2)
- RESULTDiaz-Padilla I, Siu LL, San Pedro-Salcedo M, Razak AR, Colevas AD, Shepherd FA, Leighl NB, Neal JW, Thibault A, Liu L, Lisano J, Gao B, Lawson EB, Wakelee HA. A phase I dose-escalation study of aflibercept administered in combination with pemetrexed and cisplatin in patients with advanced solid tumours. Br J Cancer. 2012 Aug 7;107(4):604-11. doi: 10.1038/bjc.2012.319. Epub 2012 Jul 17. PMID 22805331
- RESULTChen H, Modiano MR, Neal JW, Brahmer JR, Rigas JR, Jotte RM, Leighl NB, Riess JW, Kuo CJ, Liu L, Gao B, Dicioccio AT, Adjei AA, Wakelee HA. A phase II multicentre study of ziv-aflibercept in combination with cisplatin and pemetrexed in patients with previously untreated advanced/metastatic non-squamous non-small cell lung cancer. Br J Cancer. 2014 Feb 4;110(3):602-8. doi: 10.1038/bjc.2013.735. Epub 2013 Nov 28. PMID 24292447