Trial Outcomes & Findings for Vandetanib, Carboplatin, and Paclitaxel in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery (NCT NCT00459121)
NCT ID: NCT00459121
Last Updated: 2019-03-26
Results Overview
TERMINATED
PHASE2
2 participants
Following three cycles of pre-operative zactima and carboplatin/paclitaxel
2019-03-26
Participant Flow
Unable to enroll patients in a timely fashion. The decision was made to close the study after consulting with AstraZeneca.
Feasibility and safety.
Participant milestones
| Measure |
Zactima, Paclitaxel, Carboplatin
Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.
Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vandetanib, Carboplatin, and Paclitaxel in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Zactima, Paclitaxel, Carboplatin
n=2 Participants
Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.
Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Following three cycles of pre-operative zactima and carboplatin/paclitaxelPopulation: No analysis was completed only 2 patients enrolled, study closed due to slow accrual.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 30 daysPopulation: No analysis was completed only 2 patients enrolled, study closed due to slow accrual.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxelPopulation: No analysis was completed only 2 patients enrolled, study closed due to slow accrual.
Serum chemistry includes Albumin, alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, chloride, creatinine, glucose, potassium, total protein, SGOT \[AST\], SGPT \[ALT\], sodium, laboratory tests should be done on a weekly basis for the first cycle. After the first cycle laboratory tests should be done within 72 hours of each dose of carboplatin/paclitaxel.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of three cycles of treatmentPopulation: No analysis was completed only 2 patients enrolled, study closed due to slow accrual.
Patients will undergo tumor evaluation when all of the three cycles have been completed unless the treating physician has concerns regarding tumor progression. If the patient has undergone tumor evaluation prior to the last cycle the patient will require repeat tumor assessment within 4 weeks of completion of the last cycle of therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days post surgeryPopulation: No analysis was completed only 2 patients enrolled, study closed due to slow accrual.
Evaluation of the number of patients who have no evidence of tumor in the resected tumor.
Outcome measures
Outcome data not reported
Adverse Events
Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety
n=2 participants at risk
Study closed before an evaluable number of participants could be accrued. No summary of statistics will be collected for two participants, per the statistician.
|
|---|---|
|
Blood and lymphatic system disorders
Decreased ANC
|
100.0%
2/2 • Number of events 2
|
|
General disorders
Cough
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 2
|
|
Metabolism and nutrition disorders
Bicarbonate
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
2/2 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Decreased WBC count
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Decreased hemoglobin
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chills
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1
|
Additional Information
Shirish Gadgeel, M.D.
Barbara Ann Karmanos Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place