Phase II Study of ZD6474 in Advanced NSCLC

NCT00290537 | Terminated Phase 2 Results

• 1 other identifier: 2003-0635
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn how the drug ZD6474 affects the amount of tumor cell death in the body and the amount of blood that can be supplied to the tumor. The safety of ZD6474 alone and when given with chemotherapy will be studied. In addition, the side effects and response to this treatment will also be studied.

Conditions

Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Lung Cancer; Carboplatin; Paclitaxel; ZD6474; NSCLC

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Response Following Treatment With 300 mg ZD6474 Daily (Study Part One)

  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.

  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).

Study Arms (3)

Part One: ZD6474

EXPERIMENTAL

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.

Drug: ZD6474

Part Two A: ZD6474 300 mg

EXPERIMENTAL

Second part of study where participants randomized to receive 300 mg of ZD6474 daily (group A)

Drug: ZD6474

Part Two B: ZD6474 100 mg + Carboplatin + Paclitaxel

EXPERIMENTAL

Second part of study where participants randomized to receive 100 mg of ZD6474 daily plus carboplatin AUC 6.0 IV over 15-30 minutes and paclitaxel 200 mg/m\^2 IV over 3 hours on Day 1 every 3 weeks (group B).

Drug: ZD6474; Drug: Carboplatin; Drug: Paclitaxel

Interventions

ZD6474 DRUG

ZD6474 alone: Cycles 1-3 = 300 mg PO Daily x 3 Weeks; ZD6474+Carboplatin+Paclitaxel = 300 mg oral (PO) Daily or 100 mg PO Daily plus Carboplatin and Paclitaxel Every 3 Weeks.

Also known as: Zactima, Vandetanib

Part One: ZD6474; Part Two A: ZD6474 300 mg; Part Two B: ZD6474 100 mg + Carboplatin + Paclitaxel

Carboplatin DRUG

6 AUC IV Over 15-30 Minutes, Immediately After Paclitaxel

Also known as: Paraplatin

Part Two B: ZD6474 100 mg + Carboplatin + Paclitaxel

Paclitaxel DRUG

200 mg/m\^2 IV Over 3 Hours On Day 1

Also known as: Taxol

Part Two B: ZD6474 100 mg + Carboplatin + Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An informed consent form must be completed before any protocol specific screening. Patient must consent to a tissue biopsy at study entry and again at the week 3.
• Patients must have a diagnosis of stage IIIb or stage IV non-small cell lung cancer (histologically or cytologically proven) and must not be eligible for combined chemotherapy and radiation therapy.
• Patients must have at least one site of measureable disease that is amenable to biopsy. The patient must not have had radiation to this site. Lesion must be at least 20 mm in the longest diameter by spiral CT or 20 mm with conventional techniques according to RECIST.
• Eligible patients must have an ECOG performance status of 0-1.
• Patients must have adequate hepatic, renal, and bone marrow function as defined below: 1) Serum creatinine \< 1.5 mg/dL or a calculated creatinine clearance \> 60 mL/min 2)· Total bilirubin \< 1.5 x ULN ·3) ALT or AST \</= 2.5 x ULN OR ALT or AST \</= 5.0 x ULN if related to liver metastases OR Alk Phos \</= 2.5 x ULN ·4) WBC \> 3,000/mm\*\*3 ·5) ANC \> 1,500 mm\*\*3 ·6) Platelets \> 100,000/mm\*\*3 ·7) Hemoglobin \> 10 g/dL ·8) PT/PTT \< 1.5 x normal
• Patients must be \>= 18 years of age.

You may not qualify if:

• Patients are excluded if they have received prior chemotherapy for this disease type.
• Patients with brain metastases are not eligible for this study unless treated at least 4 weeks before entry and stable without steroid treatment for 1 week.
• Prior radiation therapy allowed to \<25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
• Patients may not have any concomitant uncontrolled medical or psychiatric disorders.
• Patients must not be pregnant or breast-feeding. All women of childbearing potential must have a negative pregnancy test. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy. There is no specific information available on the effects of this drug on women who are pregnant or breast-feeding. Therefore these patients are excluded from this study because of the unknown risks involved. All sexually active patients must practice adequate contraception for the entire treatment period.
• Patients must not have undergone minor surgery (e.g., central venous catheter placement) within 24 hours of treatment with ZD6474. Patients may not have undergone any major surgery (e.g., laparotomy, thoracotomy, or craniotomy) within four weeks of enrollment.
• Patients may not have a history of a bleeding diathesis.
• Patients must agree not to use herbal remedies or other over-the-counter biologics (e.g., shark cartilage)
• Significant cardiac event (including symptomatic heart failure or angina) within 3 months of entry or presence of cardiac disease that in the opinion of the Investigator increase the risk of ventricular arrythmia.
• History of clinically significant arrhythmia (multifocal PVCs, bigeminy, trigeminy, ventricular tachycardia) which is symptomatic or requires treatment (CTC grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded.
• Presence of left bundle branch block (LBBB).
• Previous history of QT prolongation as a result from other medication that required discontinuation of that medication.
• Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
• QTc with Bazett's correction that is unmeasurable, or \>/= 480 msec on screening ECG. If a patient has QTc \>/= 480 msec on screening ECG, the screening may be repeated twice (at least 24 hours apart). The average QTc from the 3 screening ECGs must be \< 480 msec in order for the patient to be eligible for the study.
• Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes (see Appendix F) or induce CYP3A4 function (see section 8.2).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Texas M.D.Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

vandetanib; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Vali Papadimitrakopoulou, MD / Associate Professor
• Organization: U.T. M.D. Anderson Cancer Center

713-792-6363

Study Officials

• Vassiliki Papadimitrakopoulou, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2006
• First Posted: February 13, 2006
• Study Start: January 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 19, 2016
• Results First Posted: June 23, 2009

Record last verified: 2009-08

Locations

US (1)