Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or Carboplatin
A Phase II Trial of Intravenous Gemcitabine (NSC #613327) and Intraperitoneal Carboplatin (NSC # 241240) in the Treatment of Patients With Platinum-Sensitive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma With Non-Measurable Disease
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with carboplatin works in treating patients with persistent or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that responded to previous cisplatin or carboplatin.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the progression-free survival of patients with persistent or recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with gemcitabine hydrochloride and intraperitoneal carboplatin.
- Evaluate the systemic and regional toxicity of this regimen in these patients.
Secondary
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes followed by intraperitoneal carboplatin on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
研究の種類
段階
- フェーズ2
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer
- Persistent or recurrent disease
- Nonmeasurable disease
Platinum-sensitive disease
Must have attained a clinically defined complete response after prior platinum- (cisplatin or carboplatin) and taxane-based combination chemotherapy regimen
- Patients with partial response or disease progression after first-line therapy are not eligible
- No disease recurrence within 6 months after completion of first-line platinum-taxane therapy
Must have undergone laparoscopy or laparotomy for either of the following:
Second-look surgery after a complete response to first-line therapy
- No negative second-look surgery
- Secondary cytoreductive surgery for recurrent disease ≥ 6 months after completion of first-line chemotherapy
- No greater than 1 cm residual disease at the completion of laparoscopy or laparotomy AND no diffuse carcinomatosis
Disease must be confined to the peritoneal cavity
- Retroperitoneal disease ≤ 1 cm at the completion of prior surgery allowed
- Not a candidate for a higher priority GOG protocol
- No tumors of low malignant potential
PATIENT CHARACTERISTICS:
- GOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Neuropathy (sensory and motor) ≤ grade 1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring antibiotics
- No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
- No extensive intra-abdominal adhesions
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior surgery or chemotherapy
- No prior intraperitoneal therapy
- No prior gemcitabine hydrochloride
- No more than 1 prior regimen (including consolidation chemotherapy) for ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer
- No radiotherapy to > 25% of marrow-bearing areas
- No prior abdominal-pelvic radiotherapy
- No prior cancer treatment that would preclude study therapy
No other prior therapy directed at the malignant tumor, including biological agents (unless this was part of front-line therapy), immunologic agents, vaccines, second-line chemotherapy, or hormonal therapy
- Concurrent hormone replacement therapy allowed
- No concurrent amifostine or other protective reagents
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
---|
Relative risk of progression-free survival
|
Frequency and severity of observed adverse effects by CTCAE version 3.0
|
二次結果の測定
結果測定 |
---|
Relative risk of survival
|
協力者と研究者
捜査官
- スタディチェア:Noelle G. Cloven, MD、Methodist Estabrook Cancer Center
研究記録日
主要日程の研究
研究開始
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
卵巣がんの臨床試験
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
カルボプラチンの臨床試験
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)引きこもったステージ IIIA 非小細胞肺がん | ステージ IIIB 非小細胞肺がん | 扁平上皮肺がん | 肺の腺癌 | 大細胞肺がん | ステージ IIA 非小細胞肺がん | ステージ IIB 非小細胞肺がん
-
Children's Oncology GroupNational Cancer Institute (NCI)完了脳腫瘍 | 中枢神経系腫瘍アメリカ, カナダ, オーストラリア, スイス, オランダ, ニュージーランド