Ovarian Cancer Clinical Trial
Official title:
Phase II Study of Carboplatin and Pemetrexed in Patients With Recurrent Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Cancer
NCT number | NCT00230542 |
Other study ID # | 05-220 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | September 2005 |
Est. completion date | April 2011 |
Verified date | August 2018 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the effects (good and bad) the combination of carboplatin and pemetrexed have on patients with recurrent ovarian, peritoneal, or fallopian tube cancer.
Status | Completed |
Enrollment | 44 |
Est. completion date | April 2011 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of platinum-sensitive recurrence of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer - The following histologic subtypes are eligible: papillary serous, endometrioid, mucinous, clear cell, adenocarcinomas, transitional, and mixtures of the above. - At least one measurable lesion according to RECIST criteria via CT or MRI scan - Received a platinum-containing regimen at initial diagnosis - ECOG performance status of 0,1 or 2 - 18 years of age or older - Life expectancy of greater than 12 weeks - WBC > 1,500/mm3 - Neutrophils > 1,500/mm3 - Platelets > 100,000/mm3 - Total Bilirubin < 1.5 ULN - Calculated creatinine clearance > 45 ml/min - ALT/AST < 3 x ULN (no liver mets) ALT/AST < 5 x ULN (with liver mets) - Complete recovery from completion of previous chemotherapy or biologic therapy - Negative pregnancy test and agree to practice effective method of birth control Exclusion Criteria: - Patients with sarcomatous, stromal, or germ cell elements - Prior pelvic radiotherapy > 25% of bone marrow - Uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs - Past history of bone marrow transplantation or stem cell support - Known history of CNS metastasis unless the patient has had treatment with surgery or radiation therapy, is neurologically stable, and does not require oral or intravenous corticosteroids or anticonvulsants - Prior malignancy except adequately treated carcinoma in situ of the uterine cervix, incidental stage I endometrial cancer, basal cell or squamous cell skin cancer or breast cancer (invasive or ductal carcinoma in situ) of which the patient has been disease-free for at least five years - Routine prophylactic use of G-CSF or GM-CSF or blood transfusions within 2 weeks - Clinically significant cardiac disease as defined by: history of unstable angina within 6 months; history of symptomatic ventricular arrhythmias; history of congestive heart failure; history of myocardial infarction within 6 months - Uncontrolled hypercalcemia or diabetes mellitus - Any signs of intestinal obstruction with bowel function and/or nutrition - Grade 2 or greater peripheral neuropathy - Participation in an investigational study within three weeks - History of anaphylactic shock to prior platinum chemotherapy - History of psychiatric disability or other central nervous system disorder |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Brigham and Women's Hospital, Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the response rate of carboplatin in combination with pemetrexed in patients with recurrent platinum-sensitive epithelial ovarian cancer, fallopian tube cancer or peritoneal cancer. | This study has now been published: Matulonis U.A.,Horowitz N, Campos S, Lee H., Lee J., Krasner C., Berlin S., Roche M., Duska L, Pereira L, Kendall D, Penson R. Phase II Study of Carboplatin and Pemetrexed for the Treatment of Platinum-Sensitive Recurrent Ovarian Cancer. J Clin Oncol. 2008:26(35):5761-6 | 2 years | |
Secondary | To assess time to progression, progression-free survival, and overall survival in this patient population | |||
Secondary | to assess toxicities of treatment with combination carboplatin and pemetrexed. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Withdrawn |
NCT05201001 -
APX005M in Patients With Recurrent Ovarian Cancer
|
Phase 2 | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156892 -
Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer
|
Phase 1 | |
Suspended |
NCT02432378 -
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines
|
Phase 1/Phase 2 | |
Recruiting |
NCT04533763 -
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT03371693 -
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
|
Phase 3 | |
Withdrawn |
NCT03032614 -
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
|
Phase 2 | |
Completed |
NCT01936363 -
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
|
Phase 2 | |
Completed |
NCT02019524 -
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
|
Phase 1 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
Terminated |
NCT03146663 -
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
|
Phase 2 |