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Trial Outcomes & Findings for A Study of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules in Patients With Advanced Lung Cancer (NCT NCT00153842)

NCT ID: NCT00153842

Last Updated: 2019-03-06

Results Overview

At least 6 patients will be entered onto each dose level. Doses will not be escalated over the course of treatment of an individual patient. For the purpose of this protocol, an initial-dose-limiting toxicity (IDLT) is defined as a clinical observation that is, in the judgment of the Investigator, both attributable to the administration of bexarotene and necessitates a reduction in dose, suspension or discontinuation of study drug because of a NCI CTC Grade 3 or 4 level toxicity (with the exception of elevated lipids).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

33 participants

Primary outcome timeframe

36 months

Results posted on

2019-03-06

Participant Flow

Participant milestones

Participant milestones
Measure
Phase IB
Bexarotene 300mg vs 400mg administered with paclitaxel and carboplatin
Phase II
Bexarotene 400mg in combination with Paraplatin and weekly Taxol.
Overall Study
STARTED
26
7
Overall Study
COMPLETED
26
7
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules in Patients With Advanced Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Phase IB
n=26 Participants
Bexarotene 300mg vs 400mg administered with paclitaxel and carboplatin
Phase II
n=7 Participants
Bexarotene 400mg in combination with Paraplatin and weekly Taxol.
Total
n=33 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
19 Participants
n=5 Participants
6 Participants
n=7 Participants
25 Participants
n=5 Participants
Age, Categorical
>=65 years
7 Participants
n=5 Participants
1 Participants
n=7 Participants
8 Participants
n=5 Participants
Age, Continuous
59.35 years
STANDARD_DEVIATION 9.79 • n=5 Participants
57 years
STANDARD_DEVIATION 13.99 • n=7 Participants
58.85 years
STANDARD_DEVIATION 10.61 • n=5 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
2 Participants
n=7 Participants
13 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
5 Participants
n=7 Participants
20 Participants
n=5 Participants
Region of Enrollment
United States
26 participants
n=5 Participants
7 participants
n=7 Participants
33 participants
n=5 Participants

PRIMARY outcome

Timeframe: 36 months

At least 6 patients will be entered onto each dose level. Doses will not be escalated over the course of treatment of an individual patient. For the purpose of this protocol, an initial-dose-limiting toxicity (IDLT) is defined as a clinical observation that is, in the judgment of the Investigator, both attributable to the administration of bexarotene and necessitates a reduction in dose, suspension or discontinuation of study drug because of a NCI CTC Grade 3 or 4 level toxicity (with the exception of elevated lipids).

Outcome measures

Outcome measures
Measure
Phase IB: Bexarotene 300mg, Paclitaxel and Carboplatin
n=14 Participants
Bexarotene 300mg administered with paclitaxel and carboplatin
Phase IB: Bexarotene 400mg, Paclitaxel and Carboplatin
n=12 Participants
Bexarotene 400mg administered with paclitaxel and carboplatin
Phase II
n=7 Participants
Bexarotene 400mg administered with paclitaxel and carboplatin (Paraplatin and weekly Taxol)
Bexarotene Oral Capsules Safety at Two Dose Levels (300 mg/m2 and 400 mg/m2) in Combination With Carboplatin and Taxol®.
1 participants experiencing IDLT
1 participants experiencing IDLT
0 participants experiencing IDLT

Adverse Events

Phase IB - Bexarotene 300mg, Paclitaxel and Carboplatin

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Phase IB - Bexarotene 400mg, Paclitaxel and Carboplatin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Phase II

Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Phase IB - Bexarotene 300mg, Paclitaxel and Carboplatin
n=14 participants at risk
Bexarotene 300mg administered with paclitaxel and carboplatin
Phase IB - Bexarotene 400mg, Paclitaxel and Carboplatin
n=12 participants at risk
Bexarotene 400mg administered with paclitaxel and carboplatin
Phase II
n=7 participants at risk
Bexarotene 400mg in combination with Paraplatin and weekly Taxol.
Blood and lymphatic system disorders
Myelosuppression
7.1%
1/14 • Number of events 1
0.00%
0/12
0.00%
0/7
Blood and lymphatic system disorders
Hypertriglyceridemia
0.00%
0/14
0.00%
0/12
28.6%
2/7 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

James Rigas, MD

Dartmouth-Hitchcock Medical Center

Phone: 603-650-6344

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place