A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma

Conditions

• Advanced Carcinoma
• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aflibercept — DRUG
  Administered in combination with the other two interventions via intravenous infusion.
• Pemetrexed — DRUG
  Administered in combination with the other two interventions via intravenous infusion.
• Cisplatin — DRUG
  Administered in combination with the other two interventions via intravenous infusion.

Study Details

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).

Key Dates

Start date

Nov 30, 2008

Status verified

Nov 2020

Primary completion

Jun 30, 2011

Completion

Jun 30, 2011

Study Design

Enrollment

60 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin
  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.
• Experimental: Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin
  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.
• Experimental: Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin
  Participants received intravenous infusion of aflibercept 4 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.
• Experimental: Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin
  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) for 6 cycles.

Primary Outcome Measure

Phase 1: Recommended Dose of Aflibercept for Phase 2 [ Time Frame: Phase 1: Baseline up to 315 Days ]

Locations (14)

Find similar trials in Tucson, AZ

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