A Phase 2 interventional study of Carboplatin and Paclitaxel in Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma and Recurrent Primary Peritoneal Carcinoma, sponsored by National Cancer Institute (NCI). Completed at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-08.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells. This randomized phase II trial is studying how well giving sorafenib together with paclitaxel and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).
PRIMARY OBJECTIVES :
I. Compare the progression-free and overall survival rate of patients with recurrent platinum-sensitive ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with sorafenib with or without carboplatin and paclitaxel. (Arm I [sorafenib only] closed to accrual 10/01/2008) II. Evaluate the response rate and time to disease progression in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to performance status and participating center.
ARM I (closed to accrual 10/01/2008): Patients receive oral sorafenib twice daily on days 1-28.Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II.
ARM II: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 44 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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Inclusion Criteria:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
Drug: Sorafenib Tosylate
Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Carboplatin · Drug: Paclitaxel · Drug: Sorafenib Tosylate
Given IV
Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Given IV
Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Given orally
Also known as: BAY 43-9006 Tosylate, BAY 54-9085, Nexavar, sorafenib
Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.
Time frame: after 6 weeks (2 cycles)
Evaluate the Progression-free Survival Rate
Progression free survival (PFS) was measured by months from the date of treatment to the date of death or the date of progression, and censored at the date of last follow-up for those alive without progression.
Time frame: up to 85 months of follow-up
Overall Survival
Overall survival time, in months, is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.
Time frame: up to 85 months of follow-up
Patients accrued from medical clinic from August 2004 through June 2011
| Milestone | Arm A | Arm B | Arm C |
|---|---|---|---|
| Started | 9 | 30 | 5 |
| Completed | 8 | 23 | 5 |
| Not completed | 1 | 7 | 0 |
| Withdrew: Adverse event | 0 | 4 | 0 |
| Withdrew: Withdrawal by subject | 1 | 2 | 0 |
| Withdrew: Ineligible pathology | 0 | 1 | 0 |
Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.
| participants | Arm A | Arm B | Arm C: Crossover From Arm A to B |
|---|---|---|---|
| Partial Response | 2 | 11 | 1 |
| Progressive Disease | 8 | 1 | 0 |
| Stable Disease | 3 | 7 | 4 |
| Complete Response | 0 | 4 | 0 |
Progression free survival (PFS) was measured by months from the date of treatment to the date of death or the date of progression, and censored at the date of last follow-up for those alive without progression.
| months | Arm A | Arm B | Arm C: Crossover From Arm A to B |
|---|---|---|---|
| Evaluate the Progression-free Survival Rate | 5.6 (3.4 to 17.6) | 16.8 (12.6 to 20.4) | 16.8 (12.6 to 20.4) |
Overall survival time, in months, is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.
| months | Arm A | Arm B | Arm C: Crossover From Arm A to B |
|---|---|---|---|
| Overall Survival | 25.6 (16.2 to 68.3) | 25.9 (15.4 to 42.1) | 25.9 (15.4 to 42.1) |
Collected over Adverse events collected during treatment for all patients over a 7 year period from 2004-2011.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A | — | 3/14 (21.4%) | 13/13 (100%) |
| Arm B | — | 5/30 (16.7%) | 29/29 (100%) |
| Arm C | — | 2/5 (40%) | 5/5 (100%) |
| Event | Arm A | Arm B | Arm C |
|---|---|---|---|
| Allergic reaction/hypersensitivity (including drug fever)Immune system disorders | 0/14 | 1/30 | 1/5 |
| Bowel obstructionGastrointestinal disorders | 0/14 | 0/30 | 1/5 |
| VomitingGastrointestinal disorders | 0/14 | 0/30 | 1/5 |
| Secondary Malignancy-Other, excludes metastasis from initial primaryNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/14 | 0/30 | 0/5 |
| DiarrheaGastrointestinal disorders | 1/14 | 0/30 | 0/5 |
| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)General disorders | 1/14 | 1/30 | 0/5 |
| HypokalemiaMetabolism and nutrition disorders | 1/14 | 0/30 | 0/5 |
| HyponatremiaMetabolism and nutrition disorders | 1/14 | 0/30 | 0/5 |
| Keratosis on left lateral forearmSkin and subcutaneous tissue disorders | 1/14 | 0/30 | 0/5 |
| NauseaGastrointestinal disorders | 1/14 | 0/30 | 0/5 |
| Event | Arm A | Arm B | Arm C |
|---|---|---|---|
| DiarrheaGastrointestinal disorders | 8/13 | 13/29 | 4/5 |
| Rash acneiformSkin and subcutaneous tissue disorders | 10/13 | 13/29 | 1/5 |
| Neutrophil count decreasedInvestigations | 2/13 | 22/29 | 3/5 |
| Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders | 7/13 | 22/29 | 0/5 |
| Peripheral sensory neuropathyNervous system disorders | 2/13 | 19/29 | 3/5 |
| Platelet count decreasedInvestigations | 1/13 | 19/29 | 3/5 |
| FatigueGeneral disorders | 8/13 | 18/29 | 3/5 |
| White blood cell decreasedInvestigations | 2/13 | 15/29 | 3/5 |
| NauseaGastrointestinal disorders | 4/13 | 14/29 | 2/5 |
| AlopeciaSkin and subcutaneous tissue disorders | 6/13 | 13/29 | 2/5 |
| Age, Customized(participants) | Arm A | Arm B | Arm C | Total |
|---|---|---|---|---|
| Age 40-49 | 0 | 2 | 0 | 2 |
| Age 50-59 | 4 | 15 | 0 | 19 |
| Age 60-69 | 4 | 8 | 5 | 17 |
| Age 70-79 | 1 | 5 | 0 | 6 |
| Sex: Female, Male(Participants) | Arm A | Arm B | Arm C | Total |
|---|---|---|---|---|
| Female | 9 | 30 | 5 | 44 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Arm A | Arm B | Arm C | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 8 | 22 | 5 | 35 |
| Unknown or Not Reported | 1 | 8 | 0 | 9 |
| Race (NIH/OMB)(Participants) | Arm A | Arm B | Arm C | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 9 | 24 | 5 | 38 |
| More than one race | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 5 | 0 | 5 |
| Region of Enrollment(participants) | Arm A | Arm B | Arm C | Total |
|---|---|---|---|---|
| United States | 9 | 30 | 5 | 44 |
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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