S9912 Combination Chemo in Stage III Ovarian Cancer,
This study has been completed.
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003896
First received: November 1, 1999
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: cisplatin Drug: liposomal doxorubicin Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Progression-free Survival [ Time Frame: Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter. ] [ Designated as safety issue: No ]From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.
- Overall Survival [ Time Frame: Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter. ] [ Designated as safety issue: No ]from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact
Secondary Outcome Measures:
- Adverse Events [ Time Frame: Weekly during 6 weeks of protocol treatment ] [ Designated as safety issue: Yes ]Only adverse events that are possibly, probably or definitely related to study drug are reported.
| Enrollment: | 68 |
| Study Start Date: | September 1999 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Paclitaxel/cisplatin/Liposomal Doxorubicin
paclitaxel, cisplatin and liposomal doxorubicin
|
Drug: cisplatin
Other Name: platinol
Drug: liposomal doxorubicin
Other Names:
Drug: paclitaxel
Other Name: taxol
|
Detailed Description:
OBJECTIVES:
- Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer.
- Determine the feasibility of and toxic effects associated with this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
- Tumor involves one or both ovaries with microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis
- No tumors of borderline or low malignant potential only
- Mixed Mullerian tumors allowed
- Must have optimal disease defined as no residual lesions after resection or residual disease such that no single lesion measures greater than 1 cm in diameter
- Must have undergone staging exploratory laparotomy with tumor debulking within the past 70 days
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- SWOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic:
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- SGOT or SGPT ≤ 2 times ULN
Renal:
- Creatinine clearance ≥ 50 mL/min
Cardiovascular:
- No congestive heart failure
- No cardiac arrhythmia
- No myocardial infarction or unstable angina within the past 6 months
- Patients with a history of myocardial disease must not have ischemia or pathologic arrhythmias and must have an ejection fraction > 50% by MUGA
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active or uncontrolled infection
- No concurrent fever
- No grade 2 or greater sensory neuropathy
- No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding, diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection
- No erythema or tenderness of abdominal incision or port site suggestive of underlying infection
- No other malignancy within the past five years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy for ovarian cancer
Chemotherapy:
- No prior chemotherapy for ovarian cancer
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior pelvic radiotherapy for ovarian cancer
Surgery:
- See Disease Characteristics
- Recovered from all reversible surgery-related toxic effects
Other:
- No other concurrent antitumor treatment
- No concurrent antibiotics for infection of undetermined etiology
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003896
Show 104 Study Locations
Show 104 Study LocationsSponsors and Collaborators
Southwest Oncology Group
Investigators
| Study Chair: | Harriet O. Smith, MD | University of New Mexico Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00003896 History of Changes |
| Other Study ID Numbers: | CDR0000067066, S9912, U10CA032102 |
| Study First Received: | November 1, 1999 |
| Results First Received: | October 30, 2012 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
stage III ovarian epithelial cancer peritoneal cavity cancer fallopian tube cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Cisplatin Doxorubicin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on June 17, 2013