Obatoclax Mesylate and Topotecan Hydrochloride in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer or Advanced Solid Tumors

NCT00521144 | Completed Phase 1 Results DMC

• 3 other identifiers: NCI-2009-0025207-082CDR0000561779
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

This phase I/II trial is studying the side effects and best dose of obatoclax mesylate when given together with topotecan hydrochloride and to see how well they work in treating patients with relapsed or refractory small cell lung cancer or advanced solid tumors. Obatoclax mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with topotecan hydrochloride may help kill more tumor cells

Conditions

Recurrent Small Cell Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (Phase II)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR

  Every 6 weeks, assessed up to 30 days

Study Arms (1)

Treatment (enzyme inhibitor therapy and chemotherapy)

EXPERIMENTAL

Patients receive obatoclax mesylate IV over 3 hours on day 1 OR days 1 and 3 and topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity

Drug: obatoclax mesylate; Drug: topotecan hydrochloride; Other: laboratory biomarker analysis

Interventions

obatoclax mesylate DRUG

Given IV

Also known as: GX15-070MS

Treatment (enzyme inhibitor therapy and chemotherapy)

topotecan hydrochloride DRUG

Given IV

Also known as: hycamptamine, Hycamtin, SKF S-104864-A, TOPO

Treatment (enzyme inhibitor therapy and chemotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (enzyme inhibitor therapy and chemotherapy)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed diagnosis of 1 of the following:
• Advanced solid tumor (phase I)
• Topotecan hydrochloride must be an appropriate treatment for this cancer
• Small cell lung cancer (SCLC) (phase II)
• Progressed after one prior platinum-based chemotherapy regimen
• Pathology materials (tumor tissue) will be used for correlative studies, if available
• No progressive brain metastases
• Treated brain metastases allowed provided patient is neurologically stable and does not require steroids
• No leptomeningeal involvement
• ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
• Leukocytes ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Total bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal

You may not qualify if:

• History of allergic reactions attributed to compounds of similar chemical or biological composition to obatoclax mesylate or topotecan hydrochloride (e.g., irinotecan)
• Concurrent uncontrolled illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Psychiatric illness or social situations that would limit compliance with study requirements
• History of seizure disorder or other neurological dysfunction (except peripheral neuropathy)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Paik PK, Rudin CM, Pietanza MC, Brown A, Rizvi NA, Takebe N, Travis W, James L, Ginsberg MS, Juergens R, Markus S, Tyson L, Subzwari S, Kris MG, Krug LM. A phase II study of obatoclax mesylate, a Bcl-2 antagonist, plus topotecan in relapsed small cell lung cancer. Lung Cancer. 2011 Dec;74(3):481-5. doi: 10.1016/j.lungcan.2011.05.005. Epub 2011 May 26.

  PMID: 21620511 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

obatoclax; Topotecan; trioctyl phosphine oxide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Lee Krug
• Organization: Memorial Sloan-Kettering Cancer Center

krugl@mskcc.org

646 888 4201

Study Officials

• Lee Krug

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 27, 2007
• Study Start: August 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: May 5, 2015
• Results First Posted: July 22, 2014

Record last verified: 2013-12

Locations

US (2)