Clinical trial NCT00454649
Conditions: Neoplasms
Keywords: axitinib chemotherapy anti-angiogenesis VEGF inhibition
Sponsor: Pfizer
Start date: 2005-12-01; Completion date: 2011-04-01
Enrollment: 102 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.

Detailed description:

Arms: arm 1: The following separate groups were included:

axitinib

1. plus carboplatin/paclitaxel in three different schedules
2. plus paclitaxel
3. plus docetaxel/carboplatin
4. plus docetaxel
5. plus capecitabine
6. plus gemcitabine/cisplatin
7. plus pemetrexed/cisplatin
Interventions: intervention 1: Axitinib + Paclitaxel + Carboplatin (Cohort 1) intervention 2: Axitinib + Paclitaxel + Carboplatin (Cohort 2) intervention 3: Axitinib + Paclitaxel + Carboplatin (Cohort 3) intervention 4: Axitinib + Paclitaxel (Cohort 4) intervention 5: Axitinib + Docetaxel + Carboplatin (Cohort 4a) intervention 6: Axitinib + Docetaxel (Cohort 5) intervention 7: Axitinib + Capecitabine (Cohort 6) intervention 8: Axitinib + Capecitabine (Cohort 7) intervention 9: Axitinib + Gemcitabine + Cisplatin (Cohort 8) intervention 10: Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Intervention descriptions: intervention 1: Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel \[200 milligram/square meter (mg/m\^2)\] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram\*minute/milliliter (mg\*min/mL) on Day 1 of Cycle 1 and all subsequent cycles. intervention 2: Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m\^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg\*min/mL on Day 1 of Cycle 1 and all subsequent cycles. intervention 3: Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m\^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg\*min/mL on Day 1 of Cycle 1 and all subsequent cycles. intervention 4: Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m\^2) 60-minute infusion on Day 1, 8, and 15 of each cycle. intervention 5: Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m\^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg\*min/mL on Day 1 of Cycle 1 and all subsequent cycles. intervention 6: Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m\^2) 60-minute infusion on Day 1 of each cycle. intervention 7: Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m\^2) orally BID from Day 1 to Day 14 of each cycle. intervention 8: Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m\^2) orally BID from Day 1 to Day 14 of each cycle. intervention 9: Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m\^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m\^2) infusion on Day 1 of each cycle. intervention 10: Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m\^2) 10-minute infusion followed by cisplatin (75 mg/m\^2) infusion on Day 1 of each cycle.

Protocol documents: