ZD6474 in Treating Patients With Small Cell Lung Cancer

NCT00066313 | Completed Phase 2

• 4 other identifiers: D4200C00005CAN-NCIC-BR20ZENECA-6474IL/0005CDR0000315518
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 21

Brief Summary

RATIONALE: ZD6474 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. ZD6474 may also stop the growth of small cell lung cancer by blocking blood flow to the tumor. PURPOSE: This randomized phase II trial is studying how well ZD6474 works compared to placebo in treating patients with small cell lung cancer that has responded to previous chemotherapy with or without radiation therapy.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer; limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (5)

• Overall Survival

• Response rates

• Toxicity and safety

• Pharmacokinetics

• Quality of life (QOL) as measured by EORTC QLQ-C30 and QLQ-LC13

Interventions

vandetanib DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell carcinoma of the lung * Small cell and variant histology allowed * No mixed tumors (small and large cell) * No neuroendocrine tumors of the lung * Must have received at least 4 courses of first-line combination chemotherapy as part of an induction regimen * No prior change in regimen due to disease progression * Must have achieved a radiologically confirmed (i.e., CT scan, chest x-ray, or bone scan) complete response (CR) or partial response (PR) after prior chemotherapy with or without radiotherapy AND meets 1 of the following criteria: * No more than 28 days since prior chemotherapy * At least 7 and no more than 14 days since prior radiotherapy if administered after completion of prior chemotherapy\* * No CNS metastases * Asymptomatic patients with CNS metastases who received prior therapeutic cranial irradiation and are on stable, decreasing, or no steroids are eligible * No symptomatic lesions or evidence of necrosis or bleeding NOTE: \*Randomization may take place up to 21 days after prior radiotherapy in the instance of severe esophagitis that precludes administration of oral medications PATIENT CHARACTERISTICS: Age * Over 16 Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No history of bleeding diathesis Hepatic * Bilirubin less than 1.5 times upper limit of normal (ULN) * ALT less than 2.5 times ULN Renal * Creatinine less than 1.5 times ULN * Calcium normal Cardiovascular * No prior ventricular arrhythmia that was symptomatic or required treatment (CTC grade 3), including any of the following: * Multifocal premature ventricular contractions * Bigeminy * Trigeminy * Ventricular tachycardia * No prior QT prolongation with any medication * No congenital long QT syndrome * No QT and QTc (with Bazett's correction) that is unmeasurable or is 460 msec or higher on screening ECG * No significant cardiac event, including symptomatic heart failure or angina, within the past 3 months or any cardiac disease that increases the risk for ventricular arrhythmia * No ongoing chronic atrial fibrillation * LVEF at least 45% by MUGA for patients with significant cardiac history (myocardial infarction, severe hypertension, or arrhythmia) OR who received prior doxorubicin greater than 450 mg/m\^2 Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Potassium normal * Magnesium normal * No serious active infection * No recent major bleeding * No other concurrent serious underlying medical condition that would preclude study participation * Willing and able to complete quality of life questionnaires in English or French PRIOR CONCURRENT THERAPY: Biologic therapy * No prior signal transduction inhibitors * No prior angiogenesis inhibitors * No concurrent anticancer biologic therapy or immunotherapy Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy * No concurrent anticancer radiotherapy * Concurrent low-dose, nonmyelosuppressive palliative radiotherapy allowed Surgery * More than 2 weeks since prior major surgery Other * More than 4 weeks since prior investigational drugs * No prior epidermal growth factor receptor inhibitors * No prior vascular endothelial growth factor receptor inhibitors * No concurrent CYP3A4 inhibitors or inducers, including any of the following: * Verapamil * Rifampin * Phenytoin * Carbamazepine * Barbiturates * Hypericum perforatum (St. John's wort) * No concurrent medication that affects QT/QTc and/or induces torsades de pointes * No other concurrent anticancer cytotoxic therapy * No other concurrent investigational drugs during and for 30 days after study participation * No concurrent oral bisphosphonates (e.g., clodronate) * Concurrent IV bisphosphonates allowed * No concurrent 5HT\_3 antagonists

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (21)

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Fraser/Valley Cancer Centre at British Columbia Cancer Agency

Surrey, British Columbia, V3V 1Z2, Canada

Location

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Moncton Hospital

Moncton, New Brunswick, E1C 6ZB, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

St. Catharines General Hospital at Niagara Health System

St. Catharines, Ontario, L2R 5K3, Canada

Location

Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital - Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Windsor Regional Cancer Centre at Windsor Regional Hospital

Windsor, Ontario, N8W 2X3, Canada

Location

Hopital Notre- Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

McGill Cancer Centre at McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

L'Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (1)

• Arnold AM, Seymour L, Smylie M, Ding K, Ung Y, Findlay B, Lee CW, Djurfeldt M, Whitehead M, Ellis P, Goss G, Chan A, Meharchand J, Alam Y, Gregg R, Butts C, Langmuir P, Shepherd F; National Cancer Institute of Canada Clinical Trials Group Study BR.20. Phase II study of vandetanib or placebo in small-cell lung cancer patients after complete or partial response to induction chemotherapy with or without radiation therapy: National Cancer Institute of Canada Clinical Trials Group Study BR.20. J Clin Oncol. 2007 Sep 20;25(27):4278-84. doi: 10.1200/JCO.2007.12.3083.

  PMID: 17878480 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

vandetanib; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: May 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

CA (21)