Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

• ClinicalTrials.gov Identifier: NCT00287963
• Recruitment Status: Completed
• First Posted: February 7, 2006
• Last Update Posted: May 17, 2018
• Sponsor: Medical University of South Carolina
• Information provided by (Responsible Party): Medical University of South Carolina

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Drug: topotecan hydrochloride; Drug: vinorelbine tartrate	Phase 1

Detailed Description:

OBJECTIVES:

Primary

• Determine the maximum tolerated dose of topotecan when combined with vinorelbine ditartrate in patients with recurrent lung cancer.

Secondary

• Assess the response and stable disease rates and the time to disease progression among treated patients.

OUTLINE: This is a dose-escalation study of topotecan.

Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer
• Study Start Date: February 2004
• Actual Primary Completion Date: January 2010
• Actual Study Completion Date: January 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vinorelbine + topotecan	Drug: topotecan hydrochloride; Drug: vinorelbine tartrate

Outcome Measures

Primary Outcome Measures :

1. Maximum tolerated dose [ Time Frame: Cycle 1 (up to day 21) ]

Secondary Outcome Measures :

1. Response rate [ Time Frame: while on study, at the end of each 3 week cycle ]
2. stable disease rate [ Time Frame: while on study, at the end of each 3 week cycle ]
3. time to progression [ Time Frame: from start of treatment to day of documented progression or death, whichever comes first, up to 36 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 120 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, South Carolina

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

Investigators

• Study Chair: Andrew S. Kraft, MD; Medical University of South Carolina
• Study Chair: Gustavo Leone; Medical University of South Carolina, Hollings Cancer Center

More Information

Publications of Results:

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.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT00287963
• Other Study ID Numbers: CDR0000454919; MUSC-104864/725; GSK-100780
• First Posted: February 7, 2006
• Last Update Posted: May 17, 2018
• Last Verified: May 2018

Keywords provided by Medical University of South Carolina:

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

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Topotecan; Vinorelbine; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators