Phase II Study of ZD6474 in Advanced NSCLC

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ClinicalTrials.gov Identifier: NCT00290537

Recruitment Status : Terminated (Accrual was suboptimal and increasing the number of patients was not feasible.)

First Posted : February 13, 2006

Results First Posted : June 23, 2009

Last Update Posted : May 19, 2016

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

AstraZeneca

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Lung Cancer
Interventions	Drug: ZD6474 Drug: Carboplatin Drug: Paclitaxel
Enrollment	4

Participant Flow

Recruitment Details	Recruitment Period: 01/19/2006 through 11/03/2006. All participants recruited at University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details


Arm/Group Title	Part One: ZD6474	Part Two: ZD6474 + Carboplatin + Paclitaxel
Arm/Group Description	First part of two part treatment, P...	Second part of two part treatment, ...
Arm/Group Description	First part of two part treatment, Part One: three 3-week cycles 300 mg of ZD6474 daily. Second part, Part Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 every 3 weeks	Second part of two part treatment, Part One /Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 every 3 weeks.
Period Title: Overall Study
Started	4	0
Completed	4	0
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		ZD6474
Arm/Group Description		Part One: three 3-week cycles 300 m...
Arm/Group Description		Part One: three 3-week cycles 300 mg of ZD6474 daily.
Overall Number of Baseline Participants		4
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	4 participants
		50 (35 to 58)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	4 participants
	Female	2 50.0%
	Male	2 50.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	4 participants
United States		4

Outcome Measures

1.Primary Outcome


Title	Number of Participants With Response Following Treatment With 300 mg ZD6474 Daily (Study Part One)
Description	Evaluate the response rate in patients receiving monotherapy with ZD64...
Description	Evaluate the response rate in patients receiving monotherapy with ZD6474 compared to ZD6474 plus carboplatin plus paclitaxel. No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfil the recruitment target.
Time Frame	Radiologic evaluations performed after weeks 2 and 9 of treatment, then every 2 cycles or as indicated if progressive disease is suspected up to 6 cycles or 18 weeks (1 cycle = 3 weeks).

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	ZD6474	ZD6474 + Carboplatin + Paclitaxel
Arm/Group Description:	First part of treatment: three 3-we...	Second part, patients randomized to...
Arm/Group Description:	First part of treatment: three 3-week cycles 300 mg of ZD6474 daily. Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.	Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
Overall Number of Participants Analyzed	4	0
Measure Type: Number Unit of Measure: Participants
Complete Response	1
No Change/Stable Disease	1
Progressive Disease	1
Inevaluable for Response	1

Adverse Events

Time Frame	Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	ZD6474
Arm/Group Description	Part One: three 3-week cycles 300 m...
Arm/Group Description	Part One: three 3-week cycles 300 mg of ZD6474 daily.
All-Cause Mortality
	ZD6474
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events Serious Adverse Events
	ZD6474
	Affected / at Risk (%)	# Events
Total	0/4 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	ZD6474
	Affected / at Risk (%)	# Events
Total	4/4 (100.00%)
Blood and lymphatic system disorders
HEMORRHAGE/BLEEDIN ^† 1	1/4 (25.00%)	1
Eye disorders
VISION LOW ^† 1	2/4 (50.00%)	2
PAIN (EYE) ^† 1	1/4 (25.00%)	1
Gastrointestinal disorders
ANOREXIA ^† 1	1/4 (25.00%)	1
DIARRHEA ^† 1	2/4 (50.00%)	2
DRY MOUTH ^† 1	1/4 (25.00%)	1
INCONTINENCE, ANAL ^† 1	1/4 (25.00%)	1
NAUSEA ^† 1	1/4 (25.00%)	1
NAUSEA ALONE ^† 1	1/4 (25.00%)	1
PAIN (ABDOMEN NOS) ^† 1	1/4 (25.00%)	1
VOMITING ^† 1	1/4 (25.00%)	1
General disorders
EDEMA: LIMB ^† 1	1/4 (25.00%)	1
FATIGUE ^† 1	2/4 (50.00%)	2
Investigations
Alanine aminotransferase increased (ALT, SGPT) ^† 1	2/4 (50.00%)	2
Aspartate aminotransferase increased (AST, SGOT) ^† 1	2/4 (50.00%)	2
HEMOGLOBIN INCREASED ^† 1	1/4 (25.00%)	1
WEIGHT LOSS ^† 1	1/4 (25.00%)	1
Metabolism and nutrition disorders
HYPERGLYCEMIA ^† 1	2/4 (50.00%)	2
HYPERKALEMIA ^† 1	1/4 (25.00%)	1
HYPOALBUMINEMIA ^† 1	1/4 (25.00%)	1
HYPOKALEMIA ^† 1	2/4 (50.00%)	2
HYPOMAGNESEMIA ^† 1	1/4 (25.00%)	1
HYPONATREMIA ^† 1	1/4 (25.00%)	1
Renal and urinary disorders
PROTEINURIA ^† 1	1/4 (25.00%)	1
Respiratory, thoracic and mediastinal disorders
DYSPNEA ^† 1	1/4 (25.00%)	1
HEMORRHAGE, PULMON ^† 1	1/4 (25.00%)	1
Skin and subcutaneous tissue disorders
ALOPECIA ^† 1	1/4 (25.00%)	1
DRY SKIN ^† 1	2/4 (50.00%)	2
ERYTHEMA MULTIFORM ^† 1	2/4 (50.00%)	2
PRURITUS/ITCHING ^† 1	1/4 (25.00%)	1
RASH/DESQUAMATION ^† 1	1/4 (25.00%)	1
Vascular disorders
HYPERTENSION ^† 1	2/4 (50.00%)	2
LYMPHOPENIA ^† 1	1/4 (25.00%)	1
† Indicates events were collected by systematic assessment 1 Term from vocabulary, CTCAE (2.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Vali Papadimitrakopoulou, MD / Associate Professor
Organization:	U.T. M.D. Anderson Cancer Center
Phone:	713-792-6363

Layout table for additonal information

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00290537
Other Study ID Numbers:	2003-0635
First Submitted:	February 10, 2006
First Posted:	February 13, 2006
Results First Submitted:	March 18, 2009
Results First Posted:	June 23, 2009
Last Update Posted:	May 19, 2016

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