TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer
Sponsor
Telik (Industry)
Overall Status
Completed
CT.gov ID
NCT00102973
Collaborator
(none)
244
222
2
43
1.1
0
Study Details
Study Description
Brief Summary
The purpose of this research study is to determine if TLK286 given in combination with carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is refractory or resistant to platinum chemotherapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
244 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]
Study Start Date
:
Dec 1, 2004
Actual Primary Completion Date
:
Jul 1, 2008
Actual Study Completion Date
:
Jul 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TLK286 in Combination with Carboplatin
|
Drug: TLK286 in Combination with Carboplatin
Experimental Arm
|
| Active Comparator: Doxorubisin HCl Liposome Injection
|
Drug: Doxorubicin HCl Liposome Injection
Active Comparator
|
Outcome Measures
Primary Outcome Measures
- Study Objectives [Every 8 Weeks]
To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Are a woman 18 years of age or older
-
Have histologically or cytologically confirmed epithelial cancer of the ovary or fallopian tube, or primary peritoneal cancer
-
Have platinum refractory or resistant cancer
-
Measurable disease according to radiographic RECIST criteria with documented tumor progression
Exclusion Criteria:
-
Had treatment with first-line chemotherapy other than platinum-based regimens (carboplatin or cisplatin)
-
Have clinically significant cardiac disease
-
Have any sign of intestinal obstruction interfering with nutrition at the time of study entry
-
Are pregnant or lactating
-
Had prior treatment with liposomal doxorubicin for ovarian cancer
-
Had prior treatment with TLK286
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Little Rock Hematology Oncology | Little Rock | Arkansas | United States | 72117 |
| 2 | Arkansas Oncology Associates | Little Rock | Arkansas | United States | 72205 |
| 3 | Little Rock Hematology Oncology | Little Rock | Arkansas | United States | 72205 |
| 4 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 5 | Arkansas Oncology Associates | Little Rock | Arkansas | United States | 72207 |
| 6 | Southern California Permanente Medical Group | Anaheim | California | United States | 92807 |
| 7 | East Bay Oncology/Hematology Medical Associates, Inc. | Antioch | California | United States | 94509 |
| 8 | Southern California Permanente Medical Group | Baldwin Park | California | United States | 91706 |
| 9 | Southern California Permanente Medical Group | Bellflower | California | United States | 90706 |
| 10 | Marilyn Norton, M.D. | Chula Vista | California | United States | 91911 |
| 11 | Bay Area Cancer Research Group, LLC | Concord | California | United States | 94520 |
| 12 | East Bay Oncology/Hematology Medical Associates, Inc. | Concord | California | United States | 94520 |
| 13 | Southwest Cancer Care | Escondido | California | United States | 92025 |
| 14 | Southern California Permanente Medical Group | Fontana | California | United States | 92335 |
| 15 | California Oncology of the Central Valley | Fresno | California | United States | 93710 |
| 16 | Southern California Permanente Medical Group | Harbor City | California | United States | 90710 |
| 17 | Kaiser Permanente Medical Center | Hayward | California | United States | 94545 |
| 18 | Gynecologic Oncology Associates | La Jolla | California | United States | 92037 |
| 19 | Cancer Center Oncology Medical Group | La Mesa | California | United States | 91942 |
| 20 | LLU Faculty Medical Offices | Loma Linda | California | United States | 92354 |
| 21 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 22 | Southern California Permanente Medical Group | Los Angeles | California | United States | 90027 |
| 23 | Southern California Permanente Medical Group | Los Angeles | California | United States | 90034 |
| 24 | Bowyer Oncology Center | Los Angeles | California | United States | 90095 |
| 25 | David Geffen School of Medicine at UCLA | Los Angeles | California | United States | 90095 |
| 26 | OB/GYN Consult Suite | Los Angeles | California | United States | 90095 |
| 27 | Beverly Oncology and Imaging | Montebello | California | United States | 90640 |
| 28 | Clinical Trials and Research Associates, Inc. | Montebello | California | United States | 90640 |
| 29 | Oncology Care Medical Associates | Montebello | California | United States | 90640 |
| 30 | Southwest Cancer Care | Murrieta | California | United States | 92562 |
| 31 | Newport Imaging Center | Newport Beach | California | United States | 92660 |
| 32 | Gynecologic Oncology Associates | Newport Beach | California | United States | 92663 |
| 33 | Hoag Memorial Hospital Presbyterian | Newport Beach | California | United States | 92663 |
| 34 | Kaiser Permanente Medical Center | Oakland | California | United States | 94611 |
| 35 | N. County Oncology Medical | Oceanside | California | United States | 92056 |
| 36 | Southern California Permanente Medical Group | Panorama City | California | United States | 91402 |
| 37 | Southwest Cancer Care | Poway | California | United States | 92064 |
| 38 | Southern California Permanente Medical Group | Riverside | California | United States | 92505 |
| 39 | Kaiser Permanente Medical Center | Sacramento | California | United States | 95825 |
| 40 | Medical Oncology Associates | San Diego | California | United States | 92123 |
| 41 | Sharp Memorial Hospital - Investigational Pharmacy | San Diego | California | United States | 92123 |
| 42 | Sharp Rees-Stealy | San Diego | California | United States | 92123 |
| 43 | Kaiser Permanente Medical Center | San Francisco | California | United States | 94115 |
| 44 | Oncology Care Medical Associates | San Gabriel | California | United States | 91776 |
| 45 | Kaiser Permanente Medical Center | San Jose | California | United States | 95119 |
| 46 | Kaiser Permanente Medical Center | Santa Clara | California | United States | 95051 |
| 47 | Kaiser Permanente Medical Center | South San Francisco | California | United States | 94080 |
| 48 | Kaiser Permanente Medical Center | Vallejo | California | United States | 94589 |
| 49 | Kaiser Permanente Medical Center | Walnut Creek | California | United States | 94596 |
| 50 | Diablo Valley Oncology & Hematology Medical Group, Inc. | Walnut Creek | California | United States | 94598 |
| 51 | Oncology Care Medical Associates | Whittier | California | United States | 90602 |
| 52 | Southern Permanente Medical Group | Woodland Hills | California | United States | 91367 |
| 53 | University of Connecticut Health Center/John Dempsey Hospital | Farmington | Connecticut | United States | 06030 |
| 54 | The Center for Hematology-Oncology | Boca Raton | Florida | United States | 33486 |
| 55 | Citrus Diagnostic Center | Crystal River | Florida | United States | 34428 |
| 56 | Citrus Hematology and Oncology Center | Crystal River | Florida | United States | 34428 |
| 57 | Citrus Hematology and Oncology Center | Crystal River | Florida | United States | 34429 |
| 58 | The Center for Hematology-Oncology | Delray Beach | Florida | United States | 33484 |
| 59 | GYN Oncology Associates, Inc. | Hollywood | Florida | United States | 33021 |
| 60 | Citrus Hematology and Oncology Center | Inverness | Florida | United States | 34452 |
| 61 | Citrus Memorial Hospital Radiology Dept. | Inverness | Florida | United States | 34452 |
| 62 | Florida Wellcare Alliance, LC | Inverness | Florida | United States | 34452 |
| 63 | Shands Jacksonville Medical Center | Jacksonville | Florida | United States | 32209 |
| 64 | Palm Beach Cancer Institute | Jupiter | Florida | United States | 33458 |
| 65 | Cancer and Blood Disease Center | Lecanto | Florida | United States | 34461 |
| 66 | Florida Hospital | Orlando | Florida | United States | 32803 |
| 67 | Gynecology Oncology | Orlando | Florida | United States | 32804 |
| 68 | Florida Hospital Memorial Division - Cancer Care Center | Ormond Beach | Florida | United States | 32174 |
| 69 | Florida Hospital Memorial System | Ormond Beach | Florida | United States | 32174 |
| 70 | Palm Beach Cancer Institute | Palm Beach Gardens | Florida | United States | 33410 |
| 71 | GYN Oncology Associates, Inc. | Pembroke Pines | Florida | United States | 33028 |
| 72 | Palm Beach Cancer Institute | Wellington | Florida | United States | 33414 |
| 73 | Palm Beach Cancer Institute | West Palm Beach | Florida | United States | 33401 |
| 74 | Southeastern Gynecologic Oncology | Atlanta | Georgia | United States | 30342 |
| 75 | Southeastern Gynecologic Oncology | Lawrenceville | Georgia | United States | 30045 |
| 76 | Southeastern Gynecologic Oncology | Marietta | Georgia | United States | 30060 |
| 77 | Southeastern Gynecologic Oncology | Riverdale | Georgia | United States | 30274 |
| 78 | Memorial Health University Medical Center | Savannah | Georgia | United States | 31404 |
| 79 | Southeastern Gynecologic Oncology | Tucker | Georgia | United States | 30084 |
| 80 | Kaiser Permanente Hawaii | Honolulu | Hawaii | United States | 96819 |
| 81 | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | United States | 96826 |
| 82 | Joliet Oncology-Hematology Associates, Inc. | Flossmoor | Illinois | United States | 60422 |
| 83 | Joliet Oncology-Hematology Associates, Inc. | Joliet | Illinois | United States | 60432 |
| 84 | Joliet Oncology-Hematology Associates, Inc. | Joliet | Illinois | United States | 60435 |
| 85 | Joliet Oncology-Hematology Associates, Inc. | Kankakee | Illinois | United States | 60901 |
| 86 | Joliet Oncology-Hematology Associates, Inc. | Morris | Illinois | United States | 60450 |
| 87 | Elkhart General Hospital | Elkhart | Indiana | United States | 46514 |
| 88 | St. Vincent Hospital | Indianapolis | Indiana | United States | 46260 |
| 89 | LaPorte Hospital | LaPorte | Indiana | United States | 46350 |
| 90 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
| 91 | Saint Joseph's Regional Medical Center | South Bend | Indiana | United States | 46617 |
| 92 | James Graham Brown Cancer Center | Louisville | Kentucky | United States | 40202 |
| 93 | University Medical Center, Inc. DBA: U of L Hospital | Louisville | Kentucky | United States | 40202 |
| 94 | Hematology and Oncology Specialists, LLC | Covington | Louisiana | United States | 70433 |
| 95 | OncRx (Pharmacy) | Metairie | Louisiana | United States | 70002 |
| 96 | Hematology and Oncology Specialist | New Orleans | Louisiana | United States | 70006 |
| 97 | LSU Health Sciences Center | Shreveport | Louisiana | United States | 71103 |
| 98 | Maine Medical Center - Brighton Campus | Portland | Maine | United States | 04102 |
| 99 | Maine Medical Center | Portland | Maine | United States | 04102 |
| 100 | Maine Medical Center - Scarborough Campus | Scarborough | Maine | United States | 04074 |
| 101 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 102 | Center for Cancer and Blood Disorders, P. C. | Bethesda | Maryland | United States | 20817 |
| 103 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 104 | Dana Farber/Partners Cancer Care, Inc. | Boston | Massachusetts | United States | 02115 |
| 105 | Boston Medical Center - Center for Cancer and Blood Disorders | Boston | Massachusetts | United States | 02118 |
| 106 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 107 | Caritas St. Elizabeth's Medical Center | Boston | Massachusetts | United States | 02135 |
| 108 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 109 | Perceptive Informatics, Inc. | Waltham | Massachusetts | United States | 02451 |
| 110 | Sparrow Health System | Lansing | Michigan | United States | 48912 |
| 111 | Lakeland Hospital | Niles | Michigan | United States | 49120 |
| 112 | Providence Cancer Institute and Hospital | Southfield | Michigan | United States | 48075 |
| 113 | Lakeland Hospital | St. Joseph | Michigan | United States | 49085 |
| 114 | Duluth Clinic | Duluth | Minnesota | United States | 55805 |
| 115 | The Family Cancer Center | Olive Branch | Mississippi | United States | 38654 |
| 116 | Ellis Fischel Cancer Center | Columbia | Missouri | United States | 65203 |
| 117 | Saint Louis University | St. Louis | Missouri | United States | 63117 |
| 118 | St. John's Mercy Medical Center | St. Louis | Missouri | United States | 63141 |
| 119 | St. John's Mercy-David C. Pratt Cancer Center | St. Louis | Missouri | United States | 63141 |
| 120 | Deaconess Billings Clinic | Billings | Montana | United States | 59101 |
| 121 | Alegent Health Immanuel Medical Center | Omaha | Nebraska | United States | 68122 |
| 122 | Hematology & Oncology Consultants, PC | Omaha | Nebraska | United States | 68122 |
| 123 | Horizons West Medical Group | Scottsbluff | Nebraska | United States | 69361 |
| 124 | Odyssey Research | Scottsbluff | Nebraska | United States | 69361 |
| 125 | Regional West Medical Center | Scottsbluff | Nebraska | United States | 69361 |
| 126 | The Women's Center of Western Nebraska | Scottsbluff | Nebraska | United States | 69361 |
| 127 | Mary Hitchcock Memorial Hospital/Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 128 | A. Richard Miskoff, DO, PA | Edison | New Jersey | United States | 08818 |
| 129 | JFK Medical Center | Edison | New Jersey | United States | 08818 |
| 130 | Jersey Shore University Medical Center | Neptune | New Jersey | United States | 07754 |
| 131 | Robert Wood Johnson University Hospital | New Brunswick | New Jersey | United States | 08901 |
| 132 | The Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08901 |
| 133 | Jsumc Ob/Gyn | West Long Branch | New Jersey | United States | 07764 |
| 134 | Gynecologic Oncology & Minimally Invasive Surgery | Babylon | New York | United States | 11702 |
| 135 | The Mary Imogene Bassett Hospital | Cooperstown | New York | United States | 13326 |
| 136 | Schwartz Gynecologic Oncology | East Islip | New York | United States | 11730 |
| 137 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 138 | Hematology-Oncology Associates of Rockland | New City | New York | United States | 10956 |
| 139 | Long Island Jewish Medical Center | New Hyde Park | New York | United States | 11040 |
| 140 | The Union State Bank Cancer Center | Nyack | New York | United States | 10960 |
| 141 | Asheville Radiology | Asheville | North Carolina | United States | 28801 |
| 142 | Hope A Women's Cancer Center | Asheville | North Carolina | United States | 28816 |
| 143 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599-7570 |
| 144 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28203 |
| 145 | Inpatient Pharmacy | Charlotte | North Carolina | United States | 28203 |
| 146 | Blumenthal Cancer Center | Charlotte | North Carolina | United States | 28204 |
| 147 | Presbyterian Gynecologic Oncology | Charlotte | North Carolina | United States | 28204 |
| 148 | Presbyterian Hospital | Charlotte | North Carolina | United States | 28204 |
| 149 | Piedmont Hematology Oncology Associates | Winston Salem | North Carolina | United States | 27103 |
| 150 | Cancer Care Center - Medcenter One, Inc. | Bismarck | North Dakota | United States | 58501 |
| 151 | Cancer Treatment & Research Center - Mid Dakota Clinic, P. C. | Bismarck | North Dakota | United States | 58501 |
| 152 | Odyssey Research | Bismarck | North Dakota | United States | 58501 |
| 153 | Dakota Cancer Institute | Fargo | North Dakota | United States | 58103 |
| 154 | Odyssey Research | Fargo | North Dakota | United States | 58104 |
| 155 | Barrett Cancer Center | Cincinnati | Ohio | United States | 45219-0501 |
| 156 | UC Physician's Medical Arts Building | Cincinnati | Ohio | United States | 45219 |
| 157 | University of Cincinnati Medical Center | Cincinnati | Ohio | United States | 45219 |
| 158 | Fairview Hospital Moll Pavilion | Cleveland | Ohio | United States | 44111 |
| 159 | Mid Ohio Onc/Hem (East) | Columbus | Ohio | United States | 43213 |
| 160 | GOPSA | Columbus | Ohio | United States | 43222 |
| 161 | Mid Ohio Onc/Hem (West) | Columbus | Ohio | United States | 43222 |
| 162 | Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
| 163 | Hillcrest Hospital/Cleveland Clinic Health System | Mayfield Heights | Ohio | United States | 44124 |
| 164 | Garth Phibbs, M.D., FACOG | Toledo | Ohio | United States | 43606 |
| 165 | ProMedica Health System | Toledo | Ohio | United States | 43606 |
| 166 | The Toledo Hospital | Toledo | Ohio | United States | 43606 |
| 167 | Mid Onio Onc/Hem (North) | Westerville | Ohio | United States | 43081 |
| 168 | Cancer Care Associates | Tulsa | Oklahoma | United States | 74104 |
| 169 | Cancer Care Associates | Tulsa | Oklahoma | United States | 74136 |
| 170 | Kaiser Permanente Northwest Region | Portland | Oregon | United States | 97227 |
| 171 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
| 172 | Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
| 173 | Advance Imaging | Dunmore | Pennsylvania | United States | 18512 |
| 174 | Hematology & Oncology Associates of NEPA | Dunmore | Pennsylvania | United States | 18512 |
| 175 | Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | United States | 15213 |
| 176 | Hematology & Oncology Associates of NEPA | Scranton | Pennsylvania | United States | 18508 |
| 177 | Viewmont Medical Services | Scranton | Pennsylvania | United States | 18508 |
| 178 | Community Medical Center | Scranton | Pennsylvania | United States | 18510 |
| 179 | Mercy Health Partners | Scranton | Pennsylvania | United States | 18510 |
| 180 | Moses Taylor Hospital | Scranton | Pennsylvania | United States | 18510 |
| 181 | Associates in Hematology-Oncology, P.C. | Upland | Pennsylvania | United States | 19013 |
| 182 | Roper Hospital-Department of Radiology | Charleston | South Carolina | United States | 29401 |
| 183 | Carolina Center of Gynecologic Oncology, PA | Charleston | South Carolina | United States | 29407 |
| 184 | South Carolina Oncology | Columbia | South Carolina | United States | 29210 |
| 185 | Greenville Hospital System | Greenville | South Carolina | United States | 29605 |
| 186 | Spartanburg Regional Healthcare System | Spartanburg | South Carolina | United States | 29303 |
| 187 | Sioux Valley Clinic - Clinical Research Center | Sioux Falls | South Dakota | United States | 57104 |
| 188 | Sioux Valley Clinic Oncology | Sioux Falls | South Dakota | United States | 57104 |
| 189 | Sioux Valley Hospital - North Center Radiology | Sioux Falls | South Dakota | United States | 57104 |
| 190 | Sioux Valley Clinic OBGYN, Ltd. | Sioux Falls | South Dakota | United States | 57105 |
| 191 | The Family Cancer Center | Bartlett | Tennessee | United States | 38133 |
| 192 | Baroness Erlander Hospital | Chattanooga | Tennessee | United States | 37403 |
| 193 | Chattanooga GYN Oncology | Chattanooga | Tennessee | United States | 37403 |
| 194 | Parkridge Medical Center | Chattanooga | Tennessee | United States | 37404 |
| 195 | The Family Cancer Center | Collierville | Tennessee | United States | 38017 |
| 196 | The Family Cancer Center | Memphis | Tennessee | United States | 38119 |
| 197 | Arlington Cancer Center | Arlington | Texas | United States | 76012 |
| 198 | Center for Oncology Research and Treatment, PA | Dallas | Texas | United States | 75230 |
| 199 | Texas Cancer Associates | Dallas | Texas | United States | 75231 |
| 200 | Texas Cancer Associates | Plano | Texas | United States | 75093 |
| 201 | Center for Oncology Research and Treatment, PA | Richardson | Texas | United States | 75080 |
| 202 | Danville Hematology and Oncology, Inc. | Danville | Virginia | United States | 24541 |
| 203 | VCU Health System at Stony Point | Richmond | Virginia | United States | 23235 |
| 204 | VCU Health System-Dalton Oncology Clinic, North Hospital | Richmond | Virginia | United States | 23298 |
| 205 | Carilion GYN Oncology Associates | Roanoke | Virginia | United States | 24014 |
| 206 | Western Washington Oncology, Inc., P.S. | Aberdeen | Washington | United States | 98520 |
| 207 | Western Washington Oncology, Inc., P. S. | Centralia | Washington | United States | 98531 |
| 208 | Covington MultiCare - Oncology Clinic | Covington | Washington | United States | 98042-4951 |
| 209 | Gig Harbor Medical Oncology | Gig Harbor | Washington | United States | 98335 |
| 210 | Western Washington Oncology, Inc., P.S. | Lacey | Washington | United States | 98503 |
| 211 | Western Washington Oncology, Inc., P.S. | Shelton | Washington | United States | 98584 |
| 212 | Allenmore Hospital - Hematology Oncology Clinic | Tacoma | Washington | United States | 98405 |
| 213 | MultiCare Health System - Medical Oncology | Tacoma | Washington | United States | 98405 |
| 214 | Marshfield Clinic - Chippewa Falls Center | Chippewa Falls | Wisconsin | United States | 54729 |
| 215 | Marshfield Clinic Cancer Care - Regional Cancer Center - Sacred Heart Hospital | Eau Claire | Wisconsin | United States | 54701 |
| 216 | Marshfield Clinic | Marshfield | Wisconsin | United States | 54449 |
| 217 | Marshfield Clinic - Lakeland Center | Minocqua | Wisconsin | United States | 54548 |
| 218 | Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin | United States | 54868 |
| 219 | St. Michael's Hospital | Stevens Point | Wisconsin | United States | 54481 |
| 220 | Marchfield Clinic - Wausau Center | Wausau | Wisconsin | United States | 54401 |
| 221 | Marshfield Clinic Weston Center | Weston | Wisconsin | United States | 54476 |
| 222 | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | United States | 54494 |
Sponsors and Collaborators
- Telik
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Telik
ClinicalTrials.gov Identifier:
NCT00102973
Other Study ID Numbers:
- TLK286.3024
First Posted:
Feb 7, 2005
Last Update Posted:
May 31, 2012
Last Verified:
Jun 1, 2006
Keywords provided by Telik
Additional relevant MeSH terms: