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Clinical Trials/NCT00555620
NCT00555620
Completed
Phase 1

A Phase 1 Study Of Sunitinib Malate In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

Pfizer1 site in 1 country76 target enrollmentMay 2008
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ConditionsStomach Neoplasms
Interventionscapecitabineoxaliplatinsunitinib malatecisplatin
Drugscapecitabineoxaliplatinsunitinib malatecisplatin

Overview

Phase
Phase 1
Intervention
capecitabine
Conditions
Stomach Neoplasms
Sponsor
Pfizer
Enrollment
76
Locations
1
Primary Endpoint
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of the study is to determine the safe and tolerable doses of sunitinib given together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients who have advanced gastric cancer who have not received prior chemotherapy for their advanced cancer

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
December 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pfizer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •confirmed diagnosis of stomach cancer
  • •advanced stomach cancer of stage IV
  • •adequate blood chemistry, blood counts and kidney function
  • •willing to participate to study requirements and sign an informed consent document

Exclusion Criteria

  • •prior chemotherapy for the stomach cancer in its advanced stage
  • •excessive toxicities related to prior therapies
  • •pregnant or breastfeeding patients

Arms & Interventions

A

Intervention: capecitabine

A

Intervention: oxaliplatin

A

Intervention: sunitinib malate

B

Intervention: capecitabine

B

Intervention: cisplatin

B

Intervention: sunitinib malate

Outcomes

Primary Outcomes

Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)

Time Frame: Baseline up to Day 21

Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having \>3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery \>14 days.

Secondary Outcomes

  • Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)(Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose))
  • Cmax of CAP(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)(Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose))
  • Cmin of CAP(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Cmin of 5'DFCR(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Cmin of 5'DFUR(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Cmin of 5-FU(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)(Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose))
  • Tmax for CAP(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Tmax for 5'DFCR(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Tmax for 5'DFUR(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Tmax for 5-FU(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)(Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose))
  • t1/2 for CAP(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • t1/2 for 5'DFCR(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • t1/2 for 5'DFUR(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • t1/2 for 5-FU(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)(Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose))
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU(Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose))
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours))
  • AUClast for 5'DFCR(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours))
  • AUClast for 5'DFUR(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours))
  • AUClast for 5-FU(Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours))
  • Percentage of Participants With Objective Response(Baseline, Day 21 of every even-numbered cycle up to 15 months)
  • Duration of Response (DR)(Baseline up to Month 15)
  • Progression-Free Survival (PFS)(Baseline up to Month 15)

Study Sites (1)

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