Small Cell Lung CancerPhase 2NCT00116610
Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer
A Phase 2 study testing picoplatin in people with Small Cell Lung Cancer, run by Poniard Pharmaceuticals at 55 sites in 3 countries.
Trial summary
This is a Phase II research study that is designed for patients who have small cell lung cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a new platinum-based agent that is currently under investigation, in 21-day cycles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- picoplatin
- How many people
- 75 participants
- Where
- 55 sitesin 3 countries
- Study dates
- Jun 2005to Mar 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Prior radiotherapy that included > 30% of the bone marrow (i.e., the whole of the pelvis or half of the spine).
- Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
- Significant heart disease.
- Uncontrolled, untreated, unstable, or symptomatic brain tumors or central nervous system disease.
- Grade 2+ peripheral neuropathy (a condition caused by damage to the nerves in the peripheral nervous system).
- [Additional exclusion criteria apply.]
Trial locations and contacts
55 sites in 3 countries.
55 sites in 3 countries
United States28 sites
Augusta Oncology Associates
Augusta, Georgia, 30901-5104
Southwest Regional Cancer Center
Austin, Texas, 78705
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, 59101
Rush Medical College
Chicago, Illinois, 60612-3828
University of Missouri / Ellis Fischel Cancer Center
Columbia, Missouri, 65203-3299
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29210
Consultants in Medical Oncology & Hematology
Drexel Hill, Pennsylvania, 19026
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534-9479
Genesis Cancer Center
Hot Springs, Arkansas, 71913
University of Kansas Medical Center
Kansas City, Kansas, 66160
Dartmouth-Hitchcock Medical Center Hematology/Oncology
Lebanon, New Hampshire, 03756
Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536
Study Site
Los Angeles, California
Central Georgia Hematology Oncology Associates
Macon, Georgia, 31201
The West Clinic
Memphis, Tennessee, 38120
Oncology Hematology Group of South Florida
Miami, Florida, 33176
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6307
The Ochsner Clinic
New Orleans, Louisiana, 70121-2483
Mt. Sinai Medical Center
New York, New York, 10029
Eastern Connecticut Hematology/Oncology
Norwich, Connecticut, 06360
Comprehensive Cancer Center
Palm Springs, California, 92262
Providence Portland Medical Center
Portland, Oregon, 97213
V.A. Sierra Nevada Health Care
Reno, Nevada, 89502
Louisiana State University Health Science Center
Shreveport, Louisiana, 71130-3932
The Center for Cancer Care & Research
St Louis, Missouri, 63141
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Georgia Cancer Specialists
Tucker, Georgia, 30084
Medical Center of Vincennes
Vincennes, Indiana, 47591
Russia25 sites
Study site
Astrakhan
Study site
Barnaul
Study site
Chelyabinsk
Study site
Cherepovets, Vologda Oblast
Study site
Engel's, Saratov Oblast
Study site
Izhevsk, Udmurtiya Republic
Study site
Kaliningrad
Study site
Kazan', Tatarstan Republic
Study site
Krasnodar
Study site
Moscow
Study site
Nizhny Novgorod
Study site
Omsk
Study site
Orenburg
Study site
Petrozavodsk, Republic of Karelia
Study site
Pyatigorsk
Study site
Rostov-on-Don
Study site
Saint Petersburg
Study site
Samara
Study site
Stavropol
Study site
Stepanovskoye, Krasnogorskiy District, Moscow Oblast
Study site
Ufa, Bashkortostan Republic
Study site
Ulyanovsk
Study site
Voronezh
Study site
Yaroslavl
Study site
Yekaterinburg
Canada2 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer
This is a Phase II research study that is designed for patients who have small cell lung cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a new platinum-based agent that is currently under investigation, in 21-day cycles.
Read the detailed description
Platinum drugs work by binding to DNA and preventing the rapid cell division of tumors. However, many tumors demonstrate a resistance to platinum drugs. Results from preclinical studies indicate that picoplatin (previously called AMD473 or ZD0473) may be able to overcome or partially overcome platinum resistance. More than 500 patients have received picoplatin in previous Phase I or Phase II clinical trials.
- Conditions
- Small Cell Lung Cancer
- Being tested
- picoplatin
- Keywords
- small cell lung cancer, resistant, refractory, platinum, chemotherapy, second-line, relapse, sensitive
- Medical subject headings
- Small Cell Lung Carcinoma, Recurrence, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
picoplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2005 (estimated)
- Study startJun 2005
- Primary completionMar 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Poniard Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hazel Breitz, MD, Study director, Poniard PharmaceuticalsPaul Weiden, MD, Study director, Poniard PharmaceuticalsDavid Karlin, MD, Study director, Poniard Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116610
- Sponsor's protocol ID
- 0402
- Other IDs
- IND No. 69,507
- Status last verified
- Feb 2007
- First submitted
- 29 Jun 2005
- Last updated
- 21 Jan 2009
- Results posted
- No
Publications
Beale P, Judson I, O'Donnell A, Trigo J, Rees C, Raynaud F, Turner A, Simmons L, Etterley L. A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473). Br J Cancer. 2003 Apr 7;88(7):1128-34. doi: 10.1038/sj.bjc.6600854.
PubMed 12671715Douillard JY, Schiller J. ZD0473 combined with other chemotherapeutic agents for the treatment of solid malignancies. Eur J Cancer. 2002 Dec;38 Suppl 8:S25-31. doi: 10.1016/s0959-8049(02)80020-x.
PubMed 12645909Gelmon KA, Stewart D, Chi KN, Chia S, Cripps C, Huan S, Janke S, Ayers D, Fry D, Shabbits JA, Walsh W, McIntosh L, Seymour LK. A phase I study of AMD473 and docetaxel given once every 3 weeks in patients with advanced refractory cancer: a National Cancer Institute of Canada-Clinical Trials Group trial, IND 131. Ann Oncol. 2004 Jul;15(7):1115-22. doi: 10.1093/annonc/mdh278.
PubMed 15205207Gelmon KA, Vandenberg TA, Panasci L, Norris B, Crump M, Douglas L, Walsh W, Matthews SJ, Seymour LK. A phase II study of ZD0473 given as a short infusion every 3 weeks to patients with advanced or metastatic breast cancer: a National Cancer Institute of Canada Clinical Trials Group trial, IND 129. Ann Oncol. 2003 Apr;14(4):543-8. doi: 10.1093/annonc/mdg171.
PubMed 12649098Giaccone G, O'Brien ME, Byrne MJ, Bard M, Kaukel E, Smit B. Phase II trial of ZD0473 as second-line therapy in mesothelioma. Eur J Cancer. 2002 Dec;38 Suppl 8:S19-24. doi: 10.1016/s0959-8049(02)80018-1.
PubMed 12647701Gore ME, Atkinson RJ, Thomas H, Cure H, Rischin D, Beale P, Bougnoux P, Dirix L, Smit WM. Results of ZD0473 in platinum-pretreated ovarian cancer: analysis according to platinum free interval. Eur J Cancer. 2002 Dec;38 Suppl 8:S7-12. doi: 10.1016/s0959-8049(02)80014-4.
PubMed 12645907Kawamura-Akiyama Y, Kusaba H, Kanzawa F, Tamura T, Saijo N, Nishio K. Non-cross resistance of ZD0473 in acquired cisplatin-resistant lung cancer cell lines. Lung Cancer. 2002 Oct;38(1):43-50. doi: 10.1016/s0169-5002(02)00175-7.
PubMed 12367792Kanzawa F, Akiyama Y, Saijo N, Nishio K. In vitro effects of combinations of cis-amminedichloro (2-methylpyridine) platinum (II) (ZD0473) with other novel anticancer drugs on the growth of SBC-3, a human small cell lung cancer cell line. Lung Cancer. 2003 Jun;40(3):325-32. doi: 10.1016/s0169-5002(03)00072-2.
PubMed 12781432Medina-Gundrum L, Cerna C, Gomez LR, Yochmowitz M, Weitman S. AMD473 (ZD0473) exhibits marked in vitro anticancer activity in human tumor specimens taken directly from patients. Anticancer Drugs. 2003 Apr;14(4):275-80. doi: 10.1097/00001813-200304000-00004.
PubMed 12679731Murakami H, Tamura T, Yamada Y, Yamamoto N, Ueda Y, Shimoyama T, Saijo N. ZD0473 pharmacokinetics in Japanese patients: a Phase I dose-escalation study. Eur J Cancer. 2002 Dec;38 Suppl 8:S1-5. doi: 10.1016/s0959-8049(02)80012-0.
PubMed 12645906Raaphorst GP, Yang DP, Li LF, Malone S. Comparison of human tumour cell responses to cisplatin and ZD0473 with and without irradiation. Anticancer Res. 2004 Mar-Apr;24(2B):613-8.
PubMed 15161002Sharp SY, O'Neill CF, Rogers P, Boxall FE, Kelland LR. Retention of activity by the new generation platinum agent AMD0473 in four human tumour cell lines possessing acquired resistance to oxaliplatin. Eur J Cancer. 2002 Nov;38(17):2309-15. doi: 10.1016/s0959-8049(02)00244-7.
PubMed 12441268Twelves C, Reck M, Anthoney A, Gatzemeier U, Kaye S. A phase I study of ZD0473 combined with paclitaxel for the treatment of solid malignancies. Cancer Chemother Pharmacol. 2003 Oct;52(4):277-81. doi: 10.1007/s00280-003-0633-9. Epub 2003 Jun 25.
PubMed 12827291Plasencia C, Abad A, Martinez-Balibrea E, Taron M. Antiproliferative effects of ZD0473 (AMD473) in combination with 5-fluorouracil or SN38 in human colorectal cancer cell lines. Invest New Drugs. 2004 Nov;22(4):399-409. doi: 10.1023/B:DRUG.0000036682.99818.71.
PubMed 15292710Treat J, Schiller J, Quoix E, Mauer A, Edelman M, Modiano M, Bonomi P, Ramlau R, Lemarie E. ZD0473 treatment in lung cancer: an overview of the clinical trial results. Eur J Cancer. 2002 Dec;38 Suppl 8:S13-8. doi: 10.1016/s0959-8049(02)80016-8.
PubMed 12645908
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00116610
- Acronym / sponsor ID
- 0402
- Conditions
- Small Cell Lung Cancer
- Keywords
- small cell lung cancer, resistant, refractory, platinum, chemotherapy, second-line, relapse, sensitive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Poniard PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 30 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II research study that is designed for patients who have small cell lung cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a new platinum-based agent that is currently under investigation, in 21-day cycles.
Detailed description
Platinum drugs work by binding to DNA and preventing the rapid cell division of tumors. However, many tumors demonstrate a resistance to platinum drugs. Results from preclinical studies indicate that picoplatin (previously called AMD473 or ZD0473) may be able to overcome or partially overcome platinum resistance. More than 500 patients have received picoplatin in previous Phase I or Phase II clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Prior radiotherapy that included > 30% of the bone marrow (i.e., the whole of the pelvis or half of the spine).
- Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
- Significant heart disease.
- Uncontrolled, untreated, unstable, or symptomatic brain tumors or central nervous system disease.
- Grade 2+ peripheral neuropathy (a condition caused by damage to the nerves in the peripheral nervous system).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| picoplatin | Drug | – |
Primary outcome
Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
- Background: PubMed 12671715Beale P, Judson I, O'Donnell A, Trigo J, Rees C, Raynaud F, Turner A, Simmons L, Etterley L. A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473). Br J Cancer. 2003 Apr 7;88(7):1128-34. doi: 10.1038/sj.bjc.6600854.
- Background: PubMed 12645909Douillard JY, Schiller J. ZD0473 combined with other chemotherapeutic agents for the treatment of solid malignancies. Eur J Cancer. 2002 Dec;38 Suppl 8:S25-31. doi: 10.1016/s0959-8049(02)80020-x.
- Background: PubMed 15205207Gelmon KA, Stewart D, Chi KN, Chia S, Cripps C, Huan S, Janke S, Ayers D, Fry D, Shabbits JA, Walsh W, McIntosh L, Seymour LK. A phase I study of AMD473 and docetaxel given once every 3 weeks in patients with advanced refractory cancer: a National Cancer Institute of Canada-Clinical Trials Group trial, IND 131. Ann Oncol. 2004 Jul;15(7):1115-22. doi: 10.1093/annonc/mdh278.
- Background: PubMed 12649098Gelmon KA, Vandenberg TA, Panasci L, Norris B, Crump M, Douglas L, Walsh W, Matthews SJ, Seymour LK. A phase II study of ZD0473 given as a short infusion every 3 weeks to patients with advanced or metastatic breast cancer: a National Cancer Institute of Canada Clinical Trials Group trial, IND 129. Ann Oncol. 2003 Apr;14(4):543-8. doi: 10.1093/annonc/mdg171.
- Background: PubMed 12647701Giaccone G, O'Brien ME, Byrne MJ, Bard M, Kaukel E, Smit B. Phase II trial of ZD0473 as second-line therapy in mesothelioma. Eur J Cancer. 2002 Dec;38 Suppl 8:S19-24. doi: 10.1016/s0959-8049(02)80018-1.
- Background: PubMed 12645907Gore ME, Atkinson RJ, Thomas H, Cure H, Rischin D, Beale P, Bougnoux P, Dirix L, Smit WM. Results of ZD0473 in platinum-pretreated ovarian cancer: analysis according to platinum free interval. Eur J Cancer. 2002 Dec;38 Suppl 8:S7-12. doi: 10.1016/s0959-8049(02)80014-4.
- Background: PubMed 12367792Kawamura-Akiyama Y, Kusaba H, Kanzawa F, Tamura T, Saijo N, Nishio K. Non-cross resistance of ZD0473 in acquired cisplatin-resistant lung cancer cell lines. Lung Cancer. 2002 Oct;38(1):43-50. doi: 10.1016/s0169-5002(02)00175-7.
- Background: PubMed 12781432Kanzawa F, Akiyama Y, Saijo N, Nishio K. In vitro effects of combinations of cis-amminedichloro (2-methylpyridine) platinum (II) (ZD0473) with other novel anticancer drugs on the growth of SBC-3, a human small cell lung cancer cell line. Lung Cancer. 2003 Jun;40(3):325-32. doi: 10.1016/s0169-5002(03)00072-2.
- Background: PubMed 12679731Medina-Gundrum L, Cerna C, Gomez LR, Yochmowitz M, Weitman S. AMD473 (ZD0473) exhibits marked in vitro anticancer activity in human tumor specimens taken directly from patients. Anticancer Drugs. 2003 Apr;14(4):275-80. doi: 10.1097/00001813-200304000-00004.
- Background: PubMed 12645906Murakami H, Tamura T, Yamada Y, Yamamoto N, Ueda Y, Shimoyama T, Saijo N. ZD0473 pharmacokinetics in Japanese patients: a Phase I dose-escalation study. Eur J Cancer. 2002 Dec;38 Suppl 8:S1-5. doi: 10.1016/s0959-8049(02)80012-0.
- Background: PubMed 15161002Raaphorst GP, Yang DP, Li LF, Malone S. Comparison of human tumour cell responses to cisplatin and ZD0473 with and without irradiation. Anticancer Res. 2004 Mar-Apr;24(2B):613-8.
- Background: PubMed 12441268Sharp SY, O'Neill CF, Rogers P, Boxall FE, Kelland LR. Retention of activity by the new generation platinum agent AMD0473 in four human tumour cell lines possessing acquired resistance to oxaliplatin. Eur J Cancer. 2002 Nov;38(17):2309-15. doi: 10.1016/s0959-8049(02)00244-7.
- Poniard Pharmaceuticals websiteLink provided by the sponsor.
- CenterWatch clinical trials listingsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazel Breitz, MD study director
Poniard Pharmaceuticals
Paul Weiden, MD study director
Poniard Pharmaceuticals
David Karlin, MD study director
Poniard Pharmaceuticals
55 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing picoplatin in people with Small Cell Lung Cancer, run by Poniard Pharmaceuticals at 55 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Russia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00116610, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2009.