Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

NCT00287963 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000454919MUSC-104864/725GSK-100780
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.

Conditions

Lung Cancer

Keywords

adenocarcinoma of the lung; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer; combined type small cell lung cancer; intermediate type small cell lung cancer; large cell lung cancer; lymphocyte-like type small cell lung cancer; recurrent non-small cell lung cancer; recurrent small cell lung cancer; squamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  Cycle 1 (up to day 21)

Secondary Outcomes (3)

• Response rate

  while on study, at the end of each 3 week cycle

• stable disease rate

  while on study, at the end of each 3 week cycle

• time to progression

  from start of treatment to day of documented progression or death, whichever comes first, up to 36 months

Study Arms (1)

Vinorelbine + topotecan

EXPERIMENTAL

Drug: topotecan hydrochloride; Drug: vinorelbine tartrate

Interventions

topotecan hydrochloride DRUG

Vinorelbine + topotecan

vinorelbine tartrate DRUG

Vinorelbine + topotecan

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed lung cancer * All histologic types eligible * Recurrent or progressive disease after ≥ 1 prior chemotherapy regimen with or without radiotherapy PATIENT CHARACTERISTICS: * ECOG performance status (PS) ≤ 2 * Karnofsky PS ≥ 60% * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Total bilirubin ≤ 1.5 mg/dL * Creatinine ≤ 1.5 mg/dL * Not pregnant or nursing * Fertile patients must use effective contraception * No other active invasive malignancy * No uncontrolled illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * No psychiatric illness/social situation that would limit compliance with study requirements * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan or vinorelbine ditartrate PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 2 weeks since prior radiotherapy * No prior therapy with topotecan or vinorelbine ditartrate * No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) * Recovered from agents administered \> 4 weeks earlier * No other concurrent investigational agents * No concurrent palliative radiotherapy * No other concurrent anticancer therapies or agents * No concurrent hormones or other chemotherapy except for the following: * Steroids for adrenal failure * Hormones for nondisease-related conditions (e.g., insulin for diabetes) * Intermittent dexamethasone as an antiemetic

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Beldner MA, Sherman CA, Green MR, Garrett-Mayer E, Chaudhary U, Meyer ML, Kraft AS, Montero AJ. Phase I dose escalation study of vinorelbine and topotecan combination chemotherapy in patients with recurrent lung cancer. BMC Cancer. 2007 Dec 20;7:231. doi: 10.1186/1471-2407-7-231.

  PMID: 18096059 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Topotecan; Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Andrew S. Kraft, MD

  Medical University of South Carolina

  STUDY CHAIR

• Gustavo Leone

  Medical University of South Carolina, Hollings Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: February 1, 2004
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

US (1)