Paclitaxel or Polyglutamate Paclitaxel or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Peritoneal Cancer or Fallopian Tube Cancer
Basic Trial Information
|Phase III||Biomarker/Laboratory analysis, Treatment||Closed||Not specified||NCI, Other||GOG-0212|
NCI-2009-00586, CDR0000422427, U10CA027469, NCT00108745
This randomized phase III trial studies paclitaxel to see how well it works compared to polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV ovarian epithelial or peritoneal cancer or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel and polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal cancer by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer.
Further Study Information
I. To determine whether CT-2103 (polyglutamate paclitaxel) or paclitaxel, administered to women with advanced ovarian, primary peritoneal or fallopian tube cancer who have attained a clinically-defined complete response to primary platinum/taxane-based chemotherapy ("consolidation/maintenance therapy") will reduce the death rate, compared to re-treatment at the time of documented disease progression.
II. To determine if, in this clinical setting, CT-2103 produces a more favorable toxicity profile (with a particular focus on peripheral neuropathy as measured by the Gynecologic Oncology Group [GOG] NTX4) and superior quality-of-life (as measured by the Functional Assessment of Cancer Therapy-Ovarian [FACT-O]), compared to paclitaxel.
I. To explore the relationship between expression of several of the angiogenic markers and overall survival or progression-free survival in patients randomized to CT-2103, paclitaxel, or no treatment.
II. To assess the association among the various tissue and serum markers of angiogenesis, and compare the ability of different combinations of these markers to predict patient outcome including overall survival and progression-free survival in patients randomized to CT-2103, paclitaxel, or no treatment.
III. To bank deoxyribonucleic acid (DNA) from whole blood for research and evaluate the association between single nucleotide polymorphisms (SNPs) and measures of clinical outcome including overall survival, progression-free survival and adverse events.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage at diagnosis (stage III vs stage IV); presence of macroscopic disease after initial debulking surgery (yes vs no); type of prior taxane-based therapy (docetaxel vs paclitaxel); and route of prior platinum therapy (intraperitoneal vs IV). Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive polyglutamate paclitaxel intravenously (IV) over 10-20 minutes on day 1.
ARM II: Patients receive paclitaxel IV over 3 hours on day 1.
ARM III: Patients receive no further anticancer treatment until evidence of disease progression.
In arms I and II, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 3, 5, and 7 of study treatment, at completion of study treatment, and then at 1 year after completion of study treatment.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 10 years.
- Patients with a histologic diagnosis of primary peritoneal carcinoma, or Stage III or IV epithelial ovarian or fallopian tube carcinoma, ,with either optimal (=< 1 cm residual disease) or suboptimal residual disease following initial surgery; all patients must have had appropriate surgery for ovarian, primary peritoneal or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
- The following histologic epithelial cell types are allowed:
- Serous adenocarcinoma
- Endometrioid adenocarcinoma
- Mucinous adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Transitional cell carcinoma
- Malignant Brenner tumor
- Adenocarcinoma not otherwise specified
- Patients must have completed treatment within the past 12 weeks with at least 5 courses and not more than 8 courses of a platinum (IV or intraperitoneal [IP]) and paclitaxel or docetaxel-based combination chemotherapy and have no symptoms suggestive of persistent cancer, normal (no evidence of cancer) computed tomography (CT) scan of the abdomen/pelvis and normal CA-125 following this therapy
- Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive diagnosis of stage III or IV epithelial ovarian, primary peritoneal or, fallopian tube (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided that they have undergone interval abdominal surgery after at least one but no more than six cycles of standard chemotherapy; such surgery must meet the same criteria as for those undergoing up front surgery, including tissue diagnosis for confirmation of primary tumor site and stage III or IV disease; also, patients must have received at least two cycles after interval abdominal surgery
- Absolute neutrophil count >= 1,500/ul
- Platelet count >= 100,000/ul
- Creatinine =< 1.5 times institutional upper limit of normal (IULN)
- Bilirubin =< 1.5 times upper limit of normal (ULN)
- Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase =< 2.5 times ULN
- Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 1
- GOG performance status of 0, 1, or 2
- Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Patients must complete pre-entry assessments
- Patients with a current diagnosis of epithelial ovarian or fallopian tube tumor of low malignant potential (LMP) (Borderline carcinomas) are not eligible; patients with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for their ovarian LMP tumor
- Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant potential tumors including so called micropapillary serous carcinomas are not eligible
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease
- Patients who have received investigational therapies, and/or biological therapies (i.e. Bevacizumab or Erlotinib) for their epithelial ovarian, primary peritoneal or fallopian tube cancers or for any other abdominal or pelvic tumor, are not excluded; however, biologics cannot be continued concurrent with the GOG-012 maintenance treatment (or observation); patients who have received prior chemotherapy for any other abdominal or pelvic tumor (except as noted above) are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease
- Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met:
- Stage not greater than I-B
- Less than 3 mm invasion without vascular or lymphatic invasion
- No poorly differentiated subtypes, including papillary serous, clear cell, or other Federation of Gynecology and Obstetrics (FIGO) Grade 3 lesions
- With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded
- Patients with acute hepatitis, or known chronic hepatitis
- Patients with an active infection that requires antibiotics
- Patients with ongoing gastrointestinal bleeding requiring blood product support
- Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up
- Patients with unstable angina or those who have had a myocardial infarction within the past six months; patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months
- Patients are excluded who have had prior therapy with CT-2103
- Patients with active bleeding or an unexplained prothrombin time (PT) or partial thromboplastin time (PTT) > institutional upper limit normal (ULN)
- Patients who are pregnant or nursing are excluded; patients who may become pregnant must practice an effective method of birth control
Trial Contact Information
Trial Lead Organizations/Sponsors
Gynecologic Oncology Group
- National Cancer Institute
Kaiser Permanente Medical Center - Los Angeles
Scott E. Lentz
Winthrop University Hospital
Jeannine A Villella
McDowell Cancer Center at Akron General Medical Center
Eric L. Jenison
Cleveland Clinic Cancer Center at Fairview Hospital
Peter Graham Rose
Cleveland Clinic Taussig Cancer Center
Peter Graham Rose
Hillcrest Cancer Center at Hillcrest Hospital
Peter Graham Rose
Geisinger Cancer Institute at Geisinger Health
James R Bosscher
AnMed Cancer Center
CCOP - Upstate Carolina
Sanford Cancer Center at Sanford USD Medical Center
Maria C. Bell
M. D. Anderson Cancer Center at University of Texas
Robert L. Coleman
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00108745
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.