Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma

Sponsor

NCIC Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00005974

Collaborator

(none)

Enrollment

Locations

98.6

Actual Duration (Months)

0.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent, locally advanced, or metastatic soft tissue sarcoma.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: alvocidib	Phase 2

Detailed Description

OBJECTIVES: I. Determine the efficacy of flavopiridol in terms of response rate in patients with previously untreated metastatic or locally advanced soft tissue sarcoma. II. Determine the toxicity of this regimen in these patients. III. Determine the time to progression, early progression rate, and response duration in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive flavopiridol IV over 1 hour daily on days 1-3. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks and then every 3 months until disease progression or death.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-18 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma

Actual Study Start Date :

Jul 4, 2000

Actual Primary Completion Date :

Nov 7, 2002

Actual Study Completion Date :

Sep 22, 2008

Outcome Measures

Primary Outcome Measures

Response Rate [2 years]
To assess the efficacy (response rate) of flavopiridol given as an N infusion daily x 3 days every 3 weeks in the patients with untreated, metastatic or locally advanced soft tissue sarcoma.

Secondary Outcome Measures

Toxicity [2 years]
To assess the toxicity of flavopiridol in patients with untreated, metastatic or locally advanced soft tissue sarcoma, as well as time to progression and early progression rate (PD within first 6 weeks), and, if responses are observed, response duration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically confirmed previously untreated metastatic or locally advanced soft tissue sarcoma not amenable to standard curative therapies Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Bone lesions are not considered measurable Must have measurable disease outside irradiated area unless evidence of progression or new lesions inside irradiated area No carcinosarcoma, Kaposi's sarcoma, soft tissue Ewing's sarcoma, or embryonal rhabdomyosarcoma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than ULN Cardiovascular: If history of cardiac disease, cardiac ejection function greater than 50% No clinically significant cardiac symptomatology Pulmonary: If history of symptomatic pulmonary disease, FEV1, FVC, and TLC greater than 60% predicted and DLCO greater than 50% predicted No clinically significant pulmonary symptomatology Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent serious disease

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplantation Chemotherapy: No prior chemotherapy for metastatic or locally advanced disease No prior high dose chemotherapy and stem cell transplantation Prior adjuvant chemotherapy allowed At least 6 months since prior chemotherapy No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No more than 25% of functioning bone marrow irradiated No concurrent radiotherapy to sole site of measurable disease Surgery: At least 4 weeks since prior major surgery Other: No other concurrent anticancer therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Mary's/Duluth Clinic Health System	Duluth	Minnesota	United States	55805
2	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2
3	Lethbridge Cancer Clinic	Lethbridge	Alberta	Canada	T1J 1W5
4	Burnaby Hospital Regional Cancer Centre	Burnaby	British Columbia	Canada	V5H 4C2
5	Nanaimo Cancer Clinic	Nanaimo	British Columbia	Canada	V9S 2B7
6	Penticton Regional Hospital	Penticton	British Columbia	Canada	V2A 3G6
7	British Columbia Cancer Agency - Fraser Valley Cancer Centre	Surrey	British Columbia	Canada	V3V 1Z2
8	Prostate Centre at Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 3J5
9	BC Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6
10	St. Paul's Hospital - Vancouver	Vancouver	British Columbia	Canada	V6Z 1Y6
11	Capital Health Region (Endeavor Clinical Research)	Victoria	British Columbia	Canada	V8V 3N1
12	Moncton Hospital	Moncton	New Brunswick	Canada	E1C 6ZB
13	Doctor Leon Richard Oncology Centre	Moncton	New Brunswick	Canada	E1C 8X3
14	Saint John Regional Hospital	Saint John	New Brunswick	Canada	E2L 4L2
15	Dr. H. Bliss Murphy Cancer Centre	St. Johns	Newfoundland and Labrador	Canada	A1B 3V6
16	Nova Scotia Cancer Centre	Halifax	Nova Scotia	Canada	B3H 1V7
17	Royal Victoria Hospital, Barrie	Barrie	Ontario	Canada	L4M 6M2
18	William Osler Health Centre	Brampton	Ontario	Canada	L6W 2Z8
19	Hamilton and Disrict Urology Association	Hamilton	Ontario	Canada	L8N 1T8
20	London Health Sciences Centre	London	Ontario	Canada	N6A 4G5
21	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
22	Markham Stouffville Hospital	Markham	Ontario	Canada	L3P 7T3
23	Trillium Health Centre	Mississauga	Ontario	Canada	L5B 1B8
24	Credit Valley Hospital	Mississauga	Ontario	Canada	L5M 2N1
25	York County Hospital	Newmarket	Ontario	Canada	L3Y 2P9
26	North York General Hospital, Ontario	North York	Ontario	Canada	M2E 1K1
27	Male Health Centre/CMX Research Inc.	Oakville	Ontario	Canada	L6H 3PI
28	Lakeridge Health Oshawa	Oshawa	Ontario	Canada	L1G 2B9
29	Ottawa Regional Cancer Centre - General Campus	Ottawa	Ontario	Canada	K1H 1C4
30	Peterborough Oncology Clinic	Peterborough	Ontario	Canada	K9H 7B6
31	Scarborough Hospital - General Site	Scarborough	Ontario	Canada	M1P 2V5
32	Hotel Dieu Hospital - St. Catharines	St. Catharines	Ontario	Canada	L2R 5K3
33	Northeastern Ontario Regional Cancer Centre, Sudbury	Sudbury	Ontario	Canada	P3E 5J1
34	Northwestern Ontario Regional Cancer Centre, Thunder Bay	Thunder Bay	Ontario	Canada	P7A 7T1
35	Toronto East General Hospital	Toronto	Ontario	Canada	M4C 3E7
36	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
37	St. Michael's Hospital - Toronto	Toronto	Ontario	Canada	M5B 1W8
38	Mount Sinai Hospital - Toronto	Toronto	Ontario	Canada	M5G 1X5
39	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4
40	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
41	Women's College Campus, Sunnybrook and Women's College Health Science Center	Toronto	Ontario	Canada	M5S 1B6
42	Saint Joseph's Health Centre - Toronto	Toronto	Ontario	Canada	M6R 1B5
43	Humber River Regional Hospital	Weston	Ontario	Canada	M9N 1N8
44	Cancer Care Ontario - Windsor Regional Cancer Centre	Windsor	Ontario	Canada	N8W 2X3
45	Queen Elizabeth Hospital, PEI	Charlottetown	Prince Edward Island	Canada	C1A 8T5
46	Centre Universitaire de Sante de l'Estrie - Site Fleurimont	Fleurimont	Quebec	Canada	J1H 5N4
47	Hopital Charles Lemoyne	Greenfield Park	Quebec	Canada	J4V 2H1
48	Centre Hospitalier Regional de Lanaudiere	Joliette	Quebec	Canada	J6E 6J2
49	Maisonneuve-Rosemont Hospital	Montreal	Quebec	Canada	H1T 2M4
50	McGill University Department of Oncology	Montreal	Quebec	Canada	H2W 1S6
51	Centre Hospitalier de l'Universite' de Montreal	Montreal	Quebec	Canada	H2W 1T8
52	Hopital Sainte Justine	Montreal	Quebec	Canada	H3T 1C5
53	Hopital Du Sacre-Coeur de Montreal	Montreal	Quebec	Canada	H4J 1C5
54	Kells Medical Research Group Inc.	Pointe Claire	Quebec	Canada	H9R 4S3
55	Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec	Quebec City	Quebec	Canada	G1R 2J6
56	Hopital du Saint-Sacrament, Quebec	Quebec City	Quebec	Canada	G1S 4L8
57	Centre Hospitalier Regional de Rimouski	Rimouski	Quebec	Canada	G5L 5T1
58	L'Hopital Laval	Ste-Foy	Quebec	Canada	G1V 4G5
59	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1
60	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada	S7N 4H4
61	Lions Gate Hospital	North Vancouver		Canada	V7L 2P9

Sponsors and Collaborators

NCIC Clinical Trials Group

Investigators

Study Chair: Donald G. Morris, MD, PhD, FRCPC, Tom Baker Cancer Centre - Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NCIC Clinical Trials Group

ClinicalTrials.gov Identifier:

NCT00005974

Other Study ID Numbers:

I136
CAN-NCIC-IND136
NCI-NCIC-136
CDR0000067961

First Posted:

May 3, 2004

Last Update Posted:

Apr 8, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by NCIC Clinical Trials Group

stage III adult soft tissue sarcoma

stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:

Sarcoma

Alvocidib

Study Results

No Results Posted as of Apr 8, 2020